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 LIU
1, Shanping MA
2, *, Zhixia XIE
2, Xiaolu CHEN
3, Hui ZHANG
3, 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
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