Article(id=1322627655355191866, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322627622589280278, 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=1582300800000, acceptedDateStr=2020-02-22, onlineDate=1793268606270, onlineDateStr=2026-10-29, pubDate=1617033600000, pubDateStr=2021-03-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793268606270, onlineIssueDateStr=2026-10-29, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793268606270, creator=13701087609, updateTime=1793268606270, updator=13701087609, issue=Issue{id=1322627622589280278, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='6', pageStart='481', pageEnd='576', issueExtLink='null', onlineDate='null', pubDate='1617033600000', pubDateStr='2021-03-30', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793268598458, creator='13701087609', updateTime=1793269229249, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322630268373021321, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322627622589280278, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322630268373021322, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322627622589280278, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=569, endPage=576, ext={EN=ArticleExt(id=1322627655678153275, articleId=1322627655355191866, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Determination of N-nitrosodimethylamine and N-nitrosodiethylamine in irbesartan by liquid chromatography-tandem mass spectrometry, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

To develop a liquid chromatography-tandem mass spectrometry method for simultaneous detection of N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) in irbesartan. APCI (+) MRM mode was selected for detection. Gradient elution was conducted with mobile phase consisting of 0.1% formic acid solution and methanol containing 0.1% formic acid. The method had good specificity. Good linearity was obtained for NDMA and NDEA in the range of 1~120 ng·mL^-1 and 0.4~48 ng·mL^-1, respectively. The limits of detection (LOD) were 0.5 ng·mL^-1 and 0.2 ng·mL^-1 for NDMA and NDEA. The relative standard deviation (RSD) of peak area was less than 3.0%. The accuracy was 96.1%~106.2% and repeatability was good. The average percent recovery was 102.5% and 99.9% for NDMA and NDEA, respectively. All samples were stable after being stored for 24 h in auto-injection sampler or at 0 ℃. This method is simple, sensitive and accurate, and can be used for limit test and quantitation of NDMA and NDEA in irbesartan.

, authors=Yan-chen ZHANG, Ling-na WANG, Xiao-qiang LIU, authorsList=Yan-chen ZHANG, Ling-na WANG, Xiao-qiang LIU, authorCompany=null, correspAuthors=Xiao-qiang LIU, 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=1322627656147915324, articleId=1322627655355191866, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=LC-MS/MS法测定厄贝沙坦中基因毒性杂质N-亚硝基二甲胺和N-亚硝基二乙胺, columnId=1236330556003242277, journalTitle=中国新药杂志, columnName=实验研究, runingTitle=null, highlight=null, articleAbstract=

建立同时检测厄贝沙坦中N-亚硝基二甲胺（NDMA）和N-亚硝基二乙胺（NDEA）的液质联用（liquid chromatography-tandem mass spectrometry，LC-MS/MS）方法。选择大气压电离串联四极杆质谱（APCI+MRM）模式进行检测，流动相为0.1%甲酸水溶液-0.1%甲酸甲醇溶液梯度洗脱。结果表明该方法专属性良好，标准曲线线性范围分别为1~120 ng·mL^-1（NDMA）和0.4~48 ng·mL^-1（NDEA）；检测限浓度分别为0.5 ng·mL^-1（NDMA）和0.2 ng·mL^-1（NDEA）；精密度RSD均<3.0%；准确度为96.1%~106.2%，重复性良好；样品的提取回收率分别为102.5%（NDMA）和99.9%（NDEA）；对照溶液在进样器和0 ℃下放置24 h后稳定。该方法简单灵敏准确，可以较好地满足厄贝沙坦原料药生产中基因毒性杂质NDMA和NDEA的检验。

, authors=张岩琛, 王玲娜, 刘晓强, authorsList=张岩琛, 王玲娜, 刘晓强, authorCompany=null, correspAuthors=刘晓强, authorNote=, correspAuthorsNote=, copyrightStatement=null, copyrightOwner=《中国新药杂志》有限公司, extLink=null, articleAbsUrl=null, sourceXml=lpn3wj18V/OrF9SPDtCy7w==, magXml=ukReWX9jMipZZQYPzFs5Hw==, pdfUrl=null, pdf=yqBy4ERh5EIsndtH8nqHfQ==, pdfFileSize=1157630, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=V0sI+Wl10Hs/bRkg0n4Gsg==, mapNumber=null, fund=null)}, authors=[Author(id=1322627657850802753, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627655355191866, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=rockluozi@126.com, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1322627658249261635, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627655355191866, authorId=1322627657850802753, language=EN, stringName=Yan-chen ZHANG, firstName=Yan-chen, middleName=null, lastName=ZHANG, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=Changzhou Food and Drug Supervision and Inspection Center, Changzhou 213000, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1322627658647720516, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627655355191866, authorId=1322627657850802753, language=CN, stringName=张岩琛, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=常州市食品药品监督检验中心，常州　213000, bio={"content":"

张岩琛，女，主管药师，主要从事药品质量和安全研究。联系电话：（0519）86629257，E-mail：rockluozi@126.com。

"}, bioImg=null, bioContent=

张岩琛，女，主管药师，主要从事药品质量和安全研究。联系电话：（0519）86629257，E-mail：rockluozi@126.com。

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