Article(id=1322901709420376542, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322901641049015115, articleNumber=null, orderNo=null, doi=null, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1605974400000, acceptedDateStr=2020-11-22, onlineDate=1793333945851, onlineDateStr=2026-10-30, pubDate=1626278400000, pubDateStr=2021-07-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793333945851, onlineIssueDateStr=2026-10-30, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793333945851, creator=13701087609, updateTime=1793333945851, updator=13701087609, issue=Issue{id=1322901641049015115, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='13', pageStart='1153', pageEnd='1248', issueExtLink='null', onlineDate='null', pubDate='1626278400000', pubDateStr='2021-07-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793333929460, creator='13701087609', updateTime=1793333989426, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322901892623376986, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322901641049015115, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322901892627571291, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322901641049015115, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1236, endPage=1241, ext={EN=ArticleExt(id=1322901709600731616, articleId=1322901709420376542, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Simultaneous determination of the contents of two genotoxic impurities in fashudil hydrochloride by LC-MS/MS, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective: To establish a liquid chromatography-tandem mass spectrometry method (LC-MS/MS method) for determination the contents of 5-methyl isoquinoline sulfonic acid (impurity A) and 5-ethyl isoquinoline sulfonic acid (impurity C) which are genotoxic impurities in fashudil hydrochloride.
Methods: The LC-MS/MS method was achieved by a Waters Symmetry C18(100 mm×3 mm, 3.5 μm) column utilizing a mobile phase of 0.1% formic acid aqueous solution-acetonitrile with gradient elution at a flow rate of 0.5 mL·min-1. The column temperature was set at 30 ℃, the injection volume was 10 μL. The electrospray was operated with the source ESI under positive ionization scanning mode, and data were collected and analyzed.
Results: Standard curves of impurity A and impurity C have a good linear relationship in the linear range. The limits of detection were 0.2 and 0.02 ng·mL-1, respectively, and the average recovery range was 93.0%~98.0%, RSD<4.67%(n=9). The RSDs of precision, accuracy, stability and durability tests were all less than 10.0%. Impurities A and C in the 3 batches of fashudil hydrochloride were not detected.
Conclusion: The established method was fast, accurate and reproducible, which could be used for the control of genotoxic impurities A and C in fashudil hydrochloride.
, authors=Xiao-na SHI
1, 2, Zhi-ying ZHANG
3, Li-shuang WANG
1, Long-shan ZHAO
1, authorsList=Xiao-na SHI, Zhi-ying ZHANG, Li-shuang WANG, Long-shan ZHAO, authorCompany=null, correspAuthors=Long-shan ZHAO, 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=1322901710414426593, articleId=1322901709420376542, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=LC-MS/MS法测定盐酸法舒地尔中2种基因毒性杂质的含量, columnId=1236330556003242277, journalTitle=中国新药杂志, columnName=实验研究, runingTitle=null, highlight=null, articleAbstract=
目的： 建立液相色谱-质谱联用法（LC-MS/MS）测定盐酸法舒地尔中2种基因毒性杂质5-异喹啉磺酸甲酯（杂质A）和5-异喹啉磺酸乙酯（杂质C）的含量测定方法，并进行方法学验证。
方法： 采用LC-MS/MS方法，使用Waters Sunfire C18（100 mm×3 mm，3.5 μm）色谱柱，以0.1%甲酸水-乙腈溶液为流动相，梯度洗脱，流速0.5 mL·min-1，柱温30 ℃，进样量10 μL。采用电子喷雾源ESI，正离子模式采集分析。
结果： 杂质A和杂质C在线性范围内线性关系良好。杂质A和杂志C的检测限分别为0.2和0.02 ng·mL-1，平均回收率均在93.0%~98.0%之间，RSD<4.67%（n=9）。准确度、稳定性和耐用性的RSD均<10.0%。3批盐酸法舒地尔中均未检测到杂质A和杂质C。
结论： 所建立的方法快捷、准确且重复性好，可用于盐酸法舒地尔中杂质A和杂质C基因毒性杂质的控制。
, authors=石小娜
1, 2, 张志英
3, 王立爽
1, 赵龙山
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