Article(id=1236700469750461224, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236700465119949418, 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=1647792000000, acceptedDateStr=2022-03-21, onlineDate=1772781968772, onlineDateStr=2026-03-06, pubDate=1681488000000, pubDateStr=2023-04-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772781968772, onlineIssueDateStr=2026-03-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772781968772, creator=13701087609, updateTime=1772781968772, updator=13701087609, issue=Issue{id=1236700465119949418, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='7', pageStart='657', pageEnd='760', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1772781967668, creator=13701087609, updateTime=1772782901622, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236704382474047808, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236700465119949418, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236704382474047809, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236700465119949418, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=742, endPage=746, ext={EN=ArticleExt(id=1236700470044062516, articleId=1236700469750461224, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Determination of three azides genotoxic impurities in irbesartan and losartan potassium active pharmaceutical ingredients by UPLC-MS/MS, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

Objective: To eatablish a UPLC-MS/MS method for determination of three azide-type genotoxics, 5-(4′-(azidomethyl)-[1,1′-biphenyl]-2-yl)-1H-tetrazole (MB-X), 4′-(azidomethyl)-[1,1′-bihenyl]-2-carbonitrile (AZBC), and 5-(4′-((5-azido-2-butyl-4-chloro-1H-imidazol-1-yl)methyl)-[1,1′-biphenyl]-2-yl)-1H-tetrazole (LADX), in active pharmaceutical ingredients (API) of irbesartan and losartan potassium.Methods:The separation was performed on a ACQUITY UPLC HSS T3 column(100 mm×2.1 mm, 1.8 μm) with the mobile phases consisting of 0.1% formic acid aqueous solution (mobile phase A) and 0.1% formic acid methanol solution (mobile phase B) using a gradient elution at a flow rate of 0.35 mL·min^-1. The column temperature was set at 50 ℃. Multiplereaction monitoring (MRM) was performed on a triple quadripole mass spectrometer equipped with a APCI source in positive/negative mode.Results:the calibration curve was linear for three compounds in the range of 0.5~100 ng·mL^-1. The recoveries (n=3) in irbesartan of low, middle, high concentration-spiked samples are 94.5%~103.5% with RSD<3.88%. The recoveries (n=3) in losartan potassium of low, middle, high concentration-spiked samples are 93.8%~100.9% with RSD<4.25%. The limits of detection are 0.05, 0.03, 0.02 ng·mL^-1 and the limits of quantification are 0.15, 0.11, 0.08 ng·mL^-1, respectively.Conclusion:The method is sensitive and accurate, which is applicable for quantification of three azide-type genotoxic impurities in irbesartan API and losartan potassium API. The method can provide reference for quality control of irbesartan and losartan potassium.

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目的：建立厄贝沙坦原料药和氯沙坦钾原料药中5-［4′-（叠氮甲基）-［1，1′-联苯］-2-基］-1H-四氮唑（MB-X），4′-叠氮甲基-［1，1′-联苯］-2-氰基（AZBC）和5-［4′-［（5-（叠氮甲基）-2-丁基-4-氯-1H-咪唑-1-基）甲基］-［1，1′-联苯］2-基］-1H-四唑（LADX）这3种叠氮类基因毒性杂质的超高效液相色谱-串联（UPLC-MS/MS）三重四级杆质谱的检测方法。方法：ACQUITY UPLC HSS T3（100 mm×2.1 mm，1.8 μm）色谱柱；0.1%甲酸水溶液为流动相A，0.1%甲酸的甲醇溶液为流动相B，梯度洗脱；流速为0.35 mL·min^-1，柱温为50 ℃；采用大气压化学离子源（APCI）正/负离子扫描，多反应监测（MRM）模式对3种基因毒性杂质同时进行定量检测。结果：3种杂质在0.5~100 ng·mL^-1范围内具有良好的线性关系；检测限分别为0.05，0.03，0.02 ng·mL^-1，定量限分别为0.15，0.11，0.08 ng·mL^-1；3种杂质在厄贝沙坦原料药中，低、中、高3个浓度的加样回收率（n=3）范围为94.5%~103.5%，相对标准偏差（RSD）<3.88%；在氯沙坦钾原料药中，低、中、高3个浓度的加样回收率（n=3）范围为93.8%~100.9%，RSD<4.25%。结论：该方法灵敏度高、专属性强，可用于测定厄贝沙坦原料药和氯沙坦钾原料药中3种叠氮类基因毒性杂质，为厄贝沙坦和氯沙坦钾的质量控制提供技术支持。

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黄海伟，男，副研究员，主要从事药品质量控制研究。E-mail: huanghw@nifdc.org.cn。

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黄海伟，男，副研究员，主要从事药品质量控制研究。E-mail: huanghw@nifdc.org.cn。

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