Article(id=1309634614818341476, tenantId=1146029695717560320, journalId=1227999776411738115, issueId=1309634614356968036, articleNumber=null, orderNo=null, doi=10.12048/j.issn.1674-229X.2026.03.003, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1757347200000, receivedDateStr=2025-09-09, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1790170824007, onlineDateStr=2026-09-23, pubDate=1774368000000, pubDateStr=2026-03-25, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1790170824007, onlineIssueDateStr=2026-09-23, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1790170824007, creator=13701087609, updateTime=1790170824007, updator=13701087609, issue=Issue{id=1309634614356968036, tenantId=1146029695717560320, journalId=1227999776411738115, year='2026', volume='36', issue='3', pageStart='161', pageEnd='240', issueExtLink='null', onlineDate='null', pubDate='1774368000000', pubDateStr='2026-03-25', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1790170823897, creator='13701087609', updateTime=1790219059643, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1309836929789682362, tenantId=1146029695717560320, journalId=1227999776411738115, issueId=1309634614356968036, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1309836929789682363, tenantId=1146029695717560320, journalId=1227999776411738115, issueId=1309634614356968036, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=175, endPage=178, ext={EN=ArticleExt(id=1309634615002890853, articleId=1309634614818341476, tenantId=1146029695717560320, journalId=1227999776411738115, language=EN, title=The Determination of Genotoxic Impurities Dimethyl Sulfate and Diethyl Sulfate in Finerenone by UPLC-MS/MS, columnId=null, journalTitle=Pharmacy Today, columnName=null, runingTitle=null, highlight=null, articleAbstract=
OBJECTIVE

To establish a UPLC-MS/MS method for the determination of genotoxic impurities dimethyl sulfate (DMS)and diethyl sulfate (DES) in Finerenone bulk drug.

METHODS

The analytes were separated on an Agilent Poroshell 120 HILIC-Z (100 mm × 2.1 mm, 2.7 μm) column. The mobile phase consisted of a formic acid, water, and acetonitrile solution in a volume ratio of 0.5:300:700 (v/v/v). The flow was set at 0.3 mL·min-1, with a column temperature of 30 ℃ . The target compounds were analyzed in the negative ion MRM mode.

RESULTS

DMS and DES showed good linear relationships within the ranges of 0.75-15.00 ng·mL-1, with correlation coefficients (r) being 0.999 9. The detection limits of the method were 0.23 μg·g-1 and the quantification limits were 0.75 μg·g-1. The recoveries were both 107.53%-109.79%. No DMS and DES were detected in 3 batches of Finerenone.

CONCLUSION

This method is accurate, specific, and sensitive. It could be used for the simultaneous determination of DMS and DES in Finerenone bulk drug, thereby providing technical support for the quality control of Finerenone.

, authors=Jian LIU1, Shanping MA2, *, Zhixia XIE2, Xiaolu CHEN3, Hui ZHANG3, authorsList=Jian LIU, Shanping MA, Zhixia XIE, Xiaolu CHEN, Hui ZHANG, authorCompany=null, correspAuthors=Shanping MA, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1309634615409738342, articleId=1309634614818341476, tenantId=1146029695717560320, journalId=1227999776411738115, language=CN, title=UPLC-MS/MS法测定非奈利酮原料药中遗传毒性杂质硫酸二甲酯和硫酸二乙酯, columnId=1228268589086606089, journalTitle=今日药学, columnName=论著, runingTitle=null, highlight=null, articleAbstract=
目的

建立超高效液相色谱-三重四极杆质谱(UPLC-MS/MS)法测定非奈利酮原料药中遗传毒性杂质硫酸二甲酯和硫酸二乙酯。

方法

采用Agilent Poroshell 120 HILIC-Z(100 mm × 2.1 mm,2.7 μm)色谱柱,流动相为甲酸-水-乙腈(0.5∶300∶700,v/v/v),流速0.3 mL·min-1,柱温30 ℃;质谱检测器,电喷雾离子源负离子模式检测,多反应监测模式。

结果

硫酸二甲酯和硫酸二乙酯在0.75~15.00 ng·mL-1范围内线性关系良好,相关系数(r)均为0.9999,方法的检出限为0.23 μg·g-1,定量限为0.75 μg·g-1,加标回收率均为107.53%~109.79%。

结论

该方法可以快速、简便、灵敏、准确地同时测定非奈利酮原料药中硫酸二甲酯和硫酸二乙酯的含量,为非奈利酮原料药的质量控制提供技术支撑。

, authors=刘健1, 马珊萍2, *, 谢志霞2, 陈小露3, 张辉3, authorsList=刘健, 马珊萍, 谢志霞, 陈小露, 张辉, authorCompany=null, correspAuthors=马珊萍, authorNote=

刘健,工程师,研究方向:药品生产技术工作

, correspAuthorsNote=

*

马珊萍,主管药师,研究方向:药品质量与安全,E-mail:
, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=v4/1E5qRb/B6LTutaafJzQ==, magXml=eVPGODN2FXmcLLmg5G0bQQ==, pdfUrl=null, pdf=dd9Ab8XWVRYKbGP8uPfcHA==, pdfFileSize=1177964, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=gPsmbl1/Wf3OdDmMbaTKpw==, mapNumber=null, fund=null)}, authors=[Author(id=1309634615954997873, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1309634616114381427, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, authorId=1309634615954997873, language=EN, stringName=Jian LIU, firstName=Jian, middleName=null, lastName=LIU, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=1, address=1.Jiangxi Xincheng Pharmaceutical Co., Ltd., Yichun, Jiangxi 336000, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1309634616181490292, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, authorId=1309634615954997873, language=CN, stringName=刘健, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=1, address=1.江西心诚药业有限公司,江西 宜春 336000, bio={"content":"

刘健,工程师,研究方向:药品生产技术工作

"}, bioImg=null, bioContent=

刘健,工程师,研究方向:药品生产技术工作

, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1309634615686562407, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, xref=1., ext=[AuthorCompanyExt(id=1309634615694951016, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, companyId=1309634615686562407, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1.Jiangxi Xincheng Pharmaceutical Co., Ltd., Yichun, Jiangxi 336000, China), AuthorCompanyExt(id=1309634615699145321, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, companyId=1309634615686562407, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1.江西心诚药业有限公司,江西 宜春 336000)])]), Author(id=1309634616261182070, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, orderNo=1, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=ma_shanping@163.com, emailSecond=null, emailThird=null, correspondingAuthor=1, authorType=1, ext={EN=AuthorExt(id=1309634616319902328, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, authorId=1309634616261182070, language=EN, stringName=Shanping MA, firstName=Shanping, middleName=null, lastName=MA, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=2, *, address=2.The People' s Hospital of Dongxiang, Fuzhou, Jiangxi 331800, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1309634618010206841, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, authorId=1309634616261182070, language=CN, stringName=马珊萍, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=2, *, address=2.江西省抚州市东乡区人民医院,江西 抚州 331800, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1309634615762059882, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, xref=2., ext=[AuthorCompanyExt(id=1309634615770448491, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, companyId=1309634615762059882, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.The People' s Hospital of Dongxiang, Fuzhou, Jiangxi 331800, China), AuthorCompanyExt(id=1309634615774642796, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, companyId=1309634615762059882, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.江西省抚州市东乡区人民医院,江西 抚州 331800)])]), Author(id=1309634618094092923, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, orderNo=2, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1309634618186367613, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, authorId=1309634618094092923, language=EN, stringName=Zhixia XIE, firstName=Zhixia, middleName=null, lastName=XIE, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=2, address=2.The People' s Hospital of Dongxiang, Fuzhou, Jiangxi 331800, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1309634618270253694, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, authorId=1309634618094092923, language=CN, stringName=谢志霞, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=2, address=2.江西省抚州市东乡区人民医院,江西 抚州 331800, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1309634615762059882, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, xref=2., ext=[AuthorCompanyExt(id=1309634615770448491, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, companyId=1309634615762059882, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.The People' s Hospital of Dongxiang, Fuzhou, Jiangxi 331800, China), AuthorCompanyExt(id=1309634615774642796, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, companyId=1309634615762059882, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.江西省抚州市东乡区人民医院,江西 抚州 331800)])]), Author(id=1309634618345751168, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, orderNo=3, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1309634618442220162, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, authorId=1309634618345751168, language=EN, stringName=Xiaolu CHEN, firstName=Xiaolu, middleName=null, lastName=CHEN, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=3, address=3.Taizhou Vocational College of Science and Technology, Taizhou, Zhejiang 318020, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1309634618521911939, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, authorId=1309634618345751168, language=CN, stringName=陈小露, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=3, address=3.台州科技职业学院,浙江 台州 318020, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1309634615837557357, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, xref=3., ext=[AuthorCompanyExt(id=1309634615850140270, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, companyId=1309634615837557357, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=3.Taizhou Vocational College of Science and Technology, Taizhou, Zhejiang 318020, China), AuthorCompanyExt(id=1309634615862723183, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, companyId=1309634615837557357, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=3.台州科技职业学院,浙江 台州 318020)])]), Author(id=1309634618597409413, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, orderNo=4, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1309634618677101191, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, authorId=1309634618597409413, language=EN, stringName=Hui ZHANG, firstName=Hui, middleName=null, lastName=ZHANG, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=3, address=3.Taizhou Vocational College of Science and Technology, Taizhou, Zhejiang 318020, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1309634618752598664, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, authorId=1309634618597409413, language=CN, stringName=张辉, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=3, address=3.台州科技职业学院,浙江 台州 318020, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1309634615837557357, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, xref=3., ext=[AuthorCompanyExt(id=1309634615850140270, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, companyId=1309634615837557357, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=3.Taizhou Vocational College of Science and Technology, Taizhou, Zhejiang 318020, China), AuthorCompanyExt(id=1309634615862723183, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, companyId=1309634615837557357, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=3.台州科技职业学院,浙江 台州 318020)])])], keywords=[Keyword(id=1309634618857456265, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, language=EN, orderNo=1, keyword=UPLC-MS/MS), Keyword(id=1309634618928759434, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, language=EN, orderNo=2, keyword=genotoxic impurities), Keyword(id=1309634618991673995, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, language=EN, orderNo=3, keyword=dimethyl sulfate), Keyword(id=1309634619062977164, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, language=EN, orderNo=4, keyword=diethyl sulfate), Keyword(id=1309634619134280333, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, language=EN, orderNo=5, keyword=finerenone), Keyword(id=1309634619209777806, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, language=CN, orderNo=1, keyword=超高效液相色谱-三重四极杆质谱), Keyword(id=1309634619281080975, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, language=CN, orderNo=2, keyword=遗传毒性杂质), Keyword(id=1309634619356578448, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, language=CN, orderNo=3, keyword=硫酸二甲酯), Keyword(id=1309634619423687313, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, language=CN, orderNo=4, keyword=硫酸二乙酯), Keyword(id=1309634619499184786, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, language=CN, orderNo=5, keyword=非奈利酮)], refs=null, funds=[Fund(id=1309634619625013907, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, awardId=LGN22B020002, language=CN, fundingSource=浙江省基础公益研究计划(LGN22B020002), fundOrder=null, country=null), Fund(id=1309634619704705684, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, awardId=24nyb10, language=CN, fundingSource=台州市科技计划项目(24nyb10), fundOrder=null, country=null)], companyList=[AuthorCompany(id=1309634615686562407, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, xref=1., ext=[AuthorCompanyExt(id=1309634615694951016, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, companyId=1309634615686562407, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1.Jiangxi Xincheng Pharmaceutical Co., Ltd., Yichun, Jiangxi 336000, China), AuthorCompanyExt(id=1309634615699145321, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, companyId=1309634615686562407, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1.江西心诚药业有限公司,江西 宜春 336000)]), AuthorCompany(id=1309634615762059882, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, xref=2., ext=[AuthorCompanyExt(id=1309634615770448491, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, companyId=1309634615762059882, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.The People' s Hospital of Dongxiang, Fuzhou, Jiangxi 331800, China), AuthorCompanyExt(id=1309634615774642796, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, companyId=1309634615762059882, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.江西省抚州市东乡区人民医院,江西 抚州 331800)]), AuthorCompany(id=1309634615837557357, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, xref=3., ext=[AuthorCompanyExt(id=1309634615850140270, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, companyId=1309634615837557357, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=3.Taizhou Vocational College of Science and Technology, Taizhou, Zhejiang 318020, China), AuthorCompanyExt(id=1309634615862723183, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, companyId=1309634615837557357, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=3.台州科技职业学院,浙江 台州 318020)])], figs=null, attaches=null, journal=Journal(id=1227999522736037889, delFlag=0, nameCn=今日药学, nameEn=Pharmacy Today, nameHistory1=null, nameHistory2=null, issn=1674-229X, eissn=null, cn=44-1650/R, coden=null, periodic=0, language=CN, oaType=null, ccby=null, superviseOffice=null, ownerOffice=null, pubOffice=null, editorOffice=null, officeType=null, aims=null, clcCode=null, officeProv=null, officeCity=null, officeAddr=null, officeZip=null, officeEmail=null, officePhone=null, editDirector=null, officeDirector=null, officeDirectorPhone=null, officeStaffNum=null, officeEmpNum=null, coverPicUrl=FY3TxpBvpOUMSCZYZYfGWg==, journalPrice=null, startedYear=null, abbrevIsoEn=Pharmacy Today, journalRemark=null, publicationField=null, createdTime=1770707501354, updatedTime=1788949008280, createdBy=18614031015, updatedBy=13041195026, firstLetterCn=J, firstLetterEn=J, subjectCode=Medical and Pharmaceutical Sciences, subjectName=null, subjectCodeEn=Medical and Pharmaceutical Sciences, subjectNameEn=null, picCn=FY3TxpBvpOUMSCZYZYfGWg==, picEn=NQ3glGuPq+e1P2N68+hOuA==, jcr=null, cjcr=null, exts=[JournalExt(id=1304509948906467610, language=CN, name=今日药学, nameHistory1=null, nameHistory2=null, managedBy=, sponsoredBy=, publishedBy=, editorOffice=, officeProv=null, officeCity=null, officeAddr=, officeZip=, editDirector=, officeDirector=null, officePhone=null, coverPicUrl=null, journalRemark=, submitArticleUrl=null, websiteUrl=, createdTime=1788949008442, updatedTime=1788949008442, createdBy=13041195026, updatedBy=13041195026, submissionGuidelinesUrl=, submissionAuthorUrl=https://yaxu.cbpt.cnki.net/index.aspx?t=1, submissionEditorUrl=https://yaxu.cbpt.cnki.net/index.aspx?t=3, submissionReviewUrl=https://yaxu.cbpt.cnki.net/index.aspx?t=2, submissionCeEditorUrl=, submissionAeEditorUrl=, option={"copyright":""}), JournalExt(id=1304509948973576475, language=EN, name=Pharmacy Today, nameHistory1=null, nameHistory2=null, managedBy=, sponsoredBy=, publishedBy=, editorOffice=, officeProv=null, officeCity=null, officeAddr=, officeZip=, editDirector=, officeDirector=null, officePhone=null, coverPicUrl=null, journalRemark=, submitArticleUrl=null, websiteUrl=, createdTime=1788949008458, updatedTime=1788949008458, createdBy=13041195026, updatedBy=13041195026, submissionGuidelinesUrl=, submissionAuthorUrl=https://yaxu.cbpt.cnki.net/index.aspx?t=1, submissionEditorUrl=https://yaxu.cbpt.cnki.net/index.aspx?t=3, submissionReviewUrl=https://yaxu.cbpt.cnki.net/index.aspx?t=2, submissionCeEditorUrl=, submissionAeEditorUrl=, option={"copyright":""})], databaseList=null, tenantJournalId=1227999776411738115, websiteList=[Website(id=1228000871989047931, webName=null, webTitle=null, webDomain=null, webCopyrigh=null, webIpcNo=null, seoTitle=null, seoKeywords=null, seoDescription=null, tenantJournalId=null, journalId=1227999776411738115, journalNameCn=null, journalNameEn=null, grayFlag=null, tenantId=1146029695717560320, platformId=null, journalGroupId=null, journalGroupNameCn=null, journalGroupNameEn=null, type=1, domain=https://castjournals.cast.org.cn/joweb/jryx/CN, language=CN, createTime=1770707823035, createBy=18614031015, updateTime=1770708039065, updateBy=18614031015, name=今日药学-中文, tplId=1146099689490845704, title=今日药学, delFlag=0, indexPage=/home, props=[WebsiteProps(id=1228002007718490824, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1228000871989047931, code=articleTextType, value=kx, createTime=1770708093814, updateTime=1770708093814, creator=18614031015, updator=18614031015), WebsiteProps(id=1228002007697519301, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1228000871989047931, code=banner, value=null, createTime=1770708093809, updateTime=1770708093809, creator=18614031015, updator=18614031015), WebsiteProps(id=1228002007747850955, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1228000871989047931, code=grayFlag, value=0, createTime=1770708093821, updateTime=1770708093821, creator=18614031015, updator=18614031015), WebsiteProps(id=1228002007693324996, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1228000871989047931, code=logo, value=https://castjournals.cast.org.cn/joweb/jryx/CN/file/pic?fileId=NhSjHI8Rs1pxX20zcTmDlg==, createTime=1770708093808, updateTime=1770708093808, creator=18614031015, updator=18614031015), WebsiteProps(id=1228002007764628173, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1228000871989047931, code=minRunFlag, value=0, createTime=1770708093825, updateTime=1770708093825, creator=18614031015, updator=18614031015), WebsiteProps(id=1228002007714296519, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1228000871989047931, code=picServerUrl, value=https://castjournals.cast.org.cn/joweb/jryx/CN/file/pic, createTime=1770708093813, updateTime=1770708093813, creator=18614031015, updator=18614031015), WebsiteProps(id=1228002007756239564, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1228000871989047931, code=silenceFlag, value=0, createTime=1770708093823, updateTime=1770708093823, creator=18614031015, updator=18614031015), WebsiteProps(id=1228002007705907910, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1228000871989047931, code=staticResourcePath, value=https://castjournals.cast.org.cn/joweb/cast_kjdb_cn_619/, createTime=1770708093811, updateTime=1770708093811, creator=18614031015, updator=18614031015), WebsiteProps(id=1228002007731073737, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1228000871989047931, code=themeColor, value=null, createTime=1770708093817, updateTime=1770708093817, creator=18614031015, updator=18614031015), WebsiteProps(id=1228002007739462346, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1228000871989047931, code=themeStyle, value=null, createTime=1770708093819, updateTime=1770708093819, creator=18614031015, updator=18614031015)]), Website(id=1228000872060351101, webName=null, webTitle=null, webDomain=null, webCopyrigh=null, webIpcNo=null, seoTitle=null, seoKeywords=null, seoDescription=null, tenantJournalId=null, journalId=1227999776411738115, journalNameCn=null, journalNameEn=null, grayFlag=null, tenantId=1146029695717560320, platformId=null, journalGroupId=null, journalGroupNameCn=null, journalGroupNameEn=null, type=1, domain=https://castjournals.cast.org.cn/joweb/jryx/EN, language=EN, createTime=1770707823052, createBy=18614031015, updateTime=1770708061891, updateBy=18614031015, name=今日药学-英文, tplId=1146101810881728533, title=Pharmacy Today, delFlag=0, indexPage=/home, props=[WebsiteProps(id=1228002043235857106, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1228000872060351101, code=articleTextType, value=kx, createTime=1770708102282, updateTime=1770708102282, creator=18614031015, updator=18614031015), WebsiteProps(id=1228002043210691279, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1228000872060351101, code=banner, value=null, createTime=1770708102276, updateTime=1770708102276, creator=18614031015, updator=18614031015), WebsiteProps(id=1228002043261022933, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1228000872060351101, code=grayFlag, value=0, createTime=1770708102288, updateTime=1770708102288, creator=18614031015, updator=18614031015), WebsiteProps(id=1228002043202302670, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1228000872060351101, code=logo, value=https://castjournals.cast.org.cn/joweb/jryx/EN/file/pic?fileId=NhSjHI8Rs1pxX20zcTmDlg==, createTime=1770708102274, updateTime=1770708102274, creator=18614031015, updator=18614031015), WebsiteProps(id=1228002043277800151, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1228000872060351101, code=minRunFlag, value=0, createTime=1770708102292, updateTime=1770708102292, creator=18614031015, updator=18614031015), WebsiteProps(id=1228002043227468497, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1228000872060351101, code=picServerUrl, value=https://castjournals.cast.org.cn/joweb/jryx/EN/file/pic, createTime=1770708102280, updateTime=1770708102280, creator=18614031015, updator=18614031015), WebsiteProps(id=1228002043269411542, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1228000872060351101, code=silenceFlag, value=0, createTime=1770708102290, updateTime=1770708102290, creator=18614031015, updator=18614031015), WebsiteProps(id=1228002043219079888, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1228000872060351101, code=staticResourcePath, value=https://castjournals.cast.org.cn/joweb/cast_kjdb_en_623/, createTime=1770708102278, updateTime=1770708102278, creator=18614031015, updator=18614031015), WebsiteProps(id=1228002043248440019, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1228000872060351101, code=themeColor, value=null, createTime=1770708102285, updateTime=1770708102285, creator=18614031015, updator=18614031015), WebsiteProps(id=1228002043252634324, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1228000872060351101, code=themeStyle, value=null, createTime=1770708102286, updateTime=1770708102286, creator=18614031015, updator=18614031015)])], journalTitle=今日药学, weixinUrl=null, journalUrl=https://yaxu.cbpt.cnki.net/, iacademicId=null, status=1, seqNo=null, journalTitleEn=Pharmacy Today, journalPhotoCn=FY3TxpBvpOUMSCZYZYfGWg==, journalPhotoEn=NQ3glGuPq+e1P2N68+hOuA==, journalFirstLetter=J, journalRecommend=null, journalNew=null, journalCollection=null, jcrJf=null, cjcrJf=null, jcrJfStr=null, cjcrJfStr=null, submissionFirstDecision=null, sciSubjectClassification=null, casSubjectClassification=null, citeScore=null, totalCitationFrequency=null, icpCode=null, psCode=null, advertisingLicenseCode=null, copyrightInformation=null, country=null, option=, provinceCode=null, provinceName=null, collectFlag=false, interPubPlatform=, interPubPlatformUrl=null), detailUrlCn=https://castjournals.cast.org.cn/joweb/jryx/CN/10.12048/j.issn.1674-229X.2026.03.003, detailUrlEn=https://castjournals.cast.org.cn/joweb/jryx/EN/10.12048/j.issn.1674-229X.2026.03.003, pdfUrlCn=https://castjournals.cast.org.cn/joweb/jryx/CN/PDF/10.12048/j.issn.1674-229X.2026.03.003, pdfUrlEn=https://castjournals.cast.org.cn/joweb/jryx/EN/PDF/10.12048/j.issn.1674-229X.2026.03.003, aliStartDate=0, aliEndDate=0, collectionFlag=false, citedCount=null, citedUrl=null, previewStatus=0, delFlag=0, hasFullText=0, orderTime=1774368000000, fullTextJson=null, articleText=null, reference=null)
收藏切换
UPLC-MS/MS法测定非奈利酮原料药中遗传毒性杂质硫酸二甲酯和硫酸二乙酯
收藏切换
PDF下载
刘健 1 , 马珊萍 2, * , 谢志霞 2 , 陈小露 3 , 张辉 3
今日药学 | 论著 2026,36(3): 175-178
收起
收藏切换
今日药学 |论著 2026 , 36 (3) : 175 -178
UPLC-MS/MS法测定非奈利酮原料药中遗传毒性杂质硫酸二甲酯和硫酸二乙酯
全屏
[Author(id=1309634615954997873, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1309634616114381427, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, authorId=1309634615954997873, language=EN, stringName=Jian LIU, firstName=Jian, middleName=null, lastName=LIU, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=1, address=1.Jiangxi Xincheng Pharmaceutical Co., Ltd., Yichun, Jiangxi 336000, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1309634616181490292, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, authorId=1309634615954997873, language=CN, stringName=刘健, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=1, address=1.江西心诚药业有限公司,江西 宜春 336000, bio={"content":"

刘健,工程师,研究方向:药品生产技术工作

"}, bioImg=null, bioContent=

刘健,工程师,研究方向:药品生产技术工作

, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1309634615686562407, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, xref=1., ext=[AuthorCompanyExt(id=1309634615694951016, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, companyId=1309634615686562407, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1.Jiangxi Xincheng Pharmaceutical Co., Ltd., Yichun, Jiangxi 336000, China), AuthorCompanyExt(id=1309634615699145321, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, companyId=1309634615686562407, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1.江西心诚药业有限公司,江西 宜春 336000)])]), Author(id=1309634616261182070, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, orderNo=1, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=ma_shanping@163.com, emailSecond=null, emailThird=null, correspondingAuthor=1, authorType=1, ext={EN=AuthorExt(id=1309634616319902328, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, authorId=1309634616261182070, language=EN, stringName=Shanping MA, firstName=Shanping, middleName=null, lastName=MA, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=2, *, address=2.The People' s Hospital of Dongxiang, Fuzhou, Jiangxi 331800, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1309634618010206841, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, authorId=1309634616261182070, language=CN, stringName=马珊萍, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=2, *, address=2.江西省抚州市东乡区人民医院,江西 抚州 331800, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1309634615762059882, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, xref=2., ext=[AuthorCompanyExt(id=1309634615770448491, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, companyId=1309634615762059882, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.The People' s Hospital of Dongxiang, Fuzhou, Jiangxi 331800, China), AuthorCompanyExt(id=1309634615774642796, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, companyId=1309634615762059882, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.江西省抚州市东乡区人民医院,江西 抚州 331800)])]), Author(id=1309634618094092923, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, orderNo=2, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1309634618186367613, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, authorId=1309634618094092923, language=EN, stringName=Zhixia XIE, firstName=Zhixia, middleName=null, lastName=XIE, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=2, address=2.The People' s Hospital of Dongxiang, Fuzhou, Jiangxi 331800, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1309634618270253694, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, authorId=1309634618094092923, language=CN, stringName=谢志霞, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=2, address=2.江西省抚州市东乡区人民医院,江西 抚州 331800, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1309634615762059882, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, xref=2., ext=[AuthorCompanyExt(id=1309634615770448491, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, companyId=1309634615762059882, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.The People' s Hospital of Dongxiang, Fuzhou, Jiangxi 331800, China), AuthorCompanyExt(id=1309634615774642796, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, companyId=1309634615762059882, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.江西省抚州市东乡区人民医院,江西 抚州 331800)])]), Author(id=1309634618345751168, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, orderNo=3, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1309634618442220162, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, authorId=1309634618345751168, language=EN, stringName=Xiaolu CHEN, firstName=Xiaolu, middleName=null, lastName=CHEN, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=3, address=3.Taizhou Vocational College of Science and Technology, Taizhou, Zhejiang 318020, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1309634618521911939, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, authorId=1309634618345751168, language=CN, stringName=陈小露, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=3, address=3.台州科技职业学院,浙江 台州 318020, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1309634615837557357, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, xref=3., ext=[AuthorCompanyExt(id=1309634615850140270, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, companyId=1309634615837557357, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=3.Taizhou Vocational College of Science and Technology, Taizhou, Zhejiang 318020, China), AuthorCompanyExt(id=1309634615862723183, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, companyId=1309634615837557357, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=3.台州科技职业学院,浙江 台州 318020)])]), Author(id=1309634618597409413, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, orderNo=4, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1309634618677101191, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, authorId=1309634618597409413, language=EN, stringName=Hui ZHANG, firstName=Hui, middleName=null, lastName=ZHANG, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=3, address=3.Taizhou Vocational College of Science and Technology, Taizhou, Zhejiang 318020, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1309634618752598664, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, authorId=1309634618597409413, language=CN, stringName=张辉, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=3, address=3.台州科技职业学院,浙江 台州 318020, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1309634615837557357, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, xref=3., ext=[AuthorCompanyExt(id=1309634615850140270, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, companyId=1309634615837557357, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=3.Taizhou Vocational College of Science and Technology, Taizhou, Zhejiang 318020, China), AuthorCompanyExt(id=1309634615862723183, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1309634614818341476, companyId=1309634615837557357, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=3.台州科技职业学院,浙江 台州 318020)])])]
刘健1, 马珊萍2, * , 谢志霞2, 陈小露3, 张辉3
作者信息
  • 1.江西心诚药业有限公司,江西 宜春 336000
  • 2.江西省抚州市东乡区人民医院,江西 抚州 331800
  • 3.台州科技职业学院,浙江 台州 318020
通讯作者:

*

马珊萍,主管药师,研究方向:药品质量与安全,E-mail:
作者简介:

刘健,工程师,研究方向:药品生产技术工作

The Determination of Genotoxic Impurities Dimethyl Sulfate and Diethyl Sulfate in Finerenone by UPLC-MS/MS
Jian LIU1, Shanping MA2, * , Zhixia XIE2, Xiaolu CHEN3, Hui ZHANG3
Affiliations
  • 1.Jiangxi Xincheng Pharmaceutical Co., Ltd., Yichun, Jiangxi 336000, China
  • 2.The People' s Hospital of Dongxiang, Fuzhou, Jiangxi 331800, China
  • 3.Taizhou Vocational College of Science and Technology, Taizhou, Zhejiang 318020, China
出版时间: 2026-03-25 doi: 10.12048/j.issn.1674-229X.2026.03.003
文章导航
收藏切换
目的

建立超高效液相色谱-三重四极杆质谱(UPLC-MS/MS)法测定非奈利酮原料药中遗传毒性杂质硫酸二甲酯和硫酸二乙酯。

方法

采用Agilent Poroshell 120 HILIC-Z(100 mm × 2.1 mm,2.7 μm)色谱柱,流动相为甲酸-水-乙腈(0.5∶300∶700,v/v/v),流速0.3 mL·min-1,柱温30 ℃;质谱检测器,电喷雾离子源负离子模式检测,多反应监测模式。

结果

硫酸二甲酯和硫酸二乙酯在0.75~15.00 ng·mL-1范围内线性关系良好,相关系数(r)均为0.9999,方法的检出限为0.23 μg·g-1,定量限为0.75 μg·g-1,加标回收率均为107.53%~109.79%。

结论

该方法可以快速、简便、灵敏、准确地同时测定非奈利酮原料药中硫酸二甲酯和硫酸二乙酯的含量,为非奈利酮原料药的质量控制提供技术支撑。

超高效液相色谱-三重四极杆质谱  /  遗传毒性杂质  /  硫酸二甲酯  /  硫酸二乙酯  /  非奈利酮
OBJECTIVE

To establish a UPLC-MS/MS method for the determination of genotoxic impurities dimethyl sulfate (DMS)and diethyl sulfate (DES) in Finerenone bulk drug.

METHODS

The analytes were separated on an Agilent Poroshell 120 HILIC-Z (100 mm × 2.1 mm, 2.7 μm) column. The mobile phase consisted of a formic acid, water, and acetonitrile solution in a volume ratio of 0.5:300:700 (v/v/v). The flow was set at 0.3 mL·min-1, with a column temperature of 30 ℃ . The target compounds were analyzed in the negative ion MRM mode.

RESULTS

DMS and DES showed good linear relationships within the ranges of 0.75-15.00 ng·mL-1, with correlation coefficients (r) being 0.999 9. The detection limits of the method were 0.23 μg·g-1 and the quantification limits were 0.75 μg·g-1. The recoveries were both 107.53%-109.79%. No DMS and DES were detected in 3 batches of Finerenone.

CONCLUSION

This method is accurate, specific, and sensitive. It could be used for the simultaneous determination of DMS and DES in Finerenone bulk drug, thereby providing technical support for the quality control of Finerenone.

UPLC-MS/MS  /  genotoxic impurities  /  dimethyl sulfate  /  diethyl sulfate  /  finerenone
刘健, 马珊萍, 谢志霞, 陈小露, 张辉. UPLC-MS/MS法测定非奈利酮原料药中遗传毒性杂质硫酸二甲酯和硫酸二乙酯. 今日药学, 2026 , 36 (3) : 175 -178 . DOI: 10.12048/j.issn.1674-229X.2026.03.003
Jian LIU, Shanping MA, Zhixia XIE, Xiaolu CHEN, Hui ZHANG. The Determination of Genotoxic Impurities Dimethyl Sulfate and Diethyl Sulfate in Finerenone by UPLC-MS/MS[J]. Pharmacy Today, 2026 , 36 (3) : 175 -178 . DOI: 10.12048/j.issn.1674-229X.2026.03.003
  • 浙江省基础公益研究计划(LGN22B020002)
  • 台州市科技计划项目(24nyb10)
参考文献 引证文献
排序方式:
2026年第36卷第3期
PDF下载
123
39
引用本文
BibTeX
文章信息
doi: 10.12048/j.issn.1674-229X.2026.03.003
  • 接收时间:2025-09-09
  • 首发时间:2026-09-23
  • 出版时间:2026-03-25
补充材料
相关文章
文章信息
作者
出版历史
  • 收稿日期:2025-09-09
基金
浙江省基础公益研究计划(LGN22B020002)
台州市科技计划项目(24nyb10)
作者信息
    1.江西心诚药业有限公司,江西 宜春 336000
    2.江西省抚州市东乡区人民医院,江西 抚州 331800
    3.台州科技职业学院,浙江 台州 318020

通讯作者:

*

马珊萍,主管药师,研究方向:药品质量与安全,E-mail:
参考文献
分享链接
https://castjournals.cast.org.cn/joweb/jryx/CN/10.12048/j.issn.1674-229X.2026.03.003
分享至
全文二维码

扫描看全文

引用本文
BibTeX
本文的引用情况
2种不同金属材料的力学参数
科
Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)
属
Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
关闭全屏