Article(id=1322246458884076101, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322246421869346895, 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=1612540800000, acceptedDateStr=2021-02-06, onlineDate=1793177721948, onlineDateStr=2026-10-28, pubDate=1624982400000, pubDateStr=2021-06-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793177721948, onlineIssueDateStr=2026-10-28, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793177721948, creator=13701087609, updateTime=1793177721948, updator=13701087609, issue=Issue{id=1322246421869346895, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='12', pageStart='1057', pageEnd='1152', issueExtLink='null', onlineDate='null', pubDate='1624982400000', pubDateStr='2021-06-30', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793177713123, creator='13701087609', updateTime=1793178158604, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322248290402414824, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322246421869346895, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322248290402414825, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322246421869346895, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1117, endPage=1125, ext={EN=ArticleExt(id=1322246459068625478, articleId=1322246458884076101, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Analysis of polymer impurities in ceftazidime averbatan sodium for injection, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective: To establish a method for determination of polymer impurities in ceftazidime averbatan sodium for injection.
Methods: Ceftazidime averbatan sodium was dissolved by water to prepare polymer stock solution. High performance size exclusion chromatography method (HPSEC) and column switching-LC/MSn method were applied to separate and deduce the poor retention impurities in polymer stock solution, and the specificity of HPSEC method was evaluated. A RP-HPLC method for polymer analysis was established with C18 column, using gradient elution by phosphate buffer solution (pH 3.2)-acetonitrile-methanol, and the RP-HPLC method was validated.
Results: Five polymers were identified in polymer stock solution, some small molecular impurities were also detected. Polymer impurities were liable to co-elute with small molecular impurities when using HPSEC method, which resulted in poor quantification accuracy and specificity. Four indicative polymer impurities were detected by RP-HPLC method with effective specificity, and no polymers related to averbatan sodium were detected.
Conclusion: HPSEC method is not suitable for the quality control of polymer impurities in ceftazidime averbatan sodium for injection, while the newly established RP-HPLC method is specific, which can effectively control the polymer impurities. The polymer impurities in the samples were all from ceftazidime, and averbatan sodium did not produce polymer impurities.
, authors=Jin LI, Shang-chen YAO, Li-hui YIN, Ming-zhe XU, Chang-qin HU, authorsList=Jin LI, Shang-chen YAO, Li-hui YIN, Ming-zhe XU, Chang-qin HU, authorCompany=null, correspAuthors=Ming-zhe XU, 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=1322246459362226759, articleId=1322246458884076101, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=注射用头孢他啶阿维巴坦钠的聚合物杂质分析, columnId=1236330556003242277, journalTitle=中国新药杂志, columnName=实验研究, runingTitle=null, highlight=null, articleAbstract=
目的： 建立注射用头孢他啶阿维巴坦钠中聚合物杂质的分析方法。
方法： 采用水为溶剂制备头孢他啶阿维巴坦钠的聚合物浓溶液；采用高效凝胶色谱法（HPSEC）和柱切换-LC/MSn法对聚合物浓溶液的弱保留值杂质进行分离和结构鉴定，并评估HPSEC法分析聚合物杂质的专属性；采用C18型反相色谱柱，以磷酸盐缓冲液（pH 3.4）-甲醇-乙腈为流动相进行梯度洗脱，建立RP-HPLC分析方法，并进行方法学验证。
结果： 在聚合物浓溶液中鉴定出5种头孢他啶的聚合物杂质以及若干小分子杂质；HPSEC法分离聚合物杂质时，小分子杂质与聚合物杂质共出峰，方法专属性与定量准确性差；RP-HPLC法分析能够检出4种头孢他啶指针性聚合物杂质，未检出与阿维巴坦钠相关的聚合物杂质。
结论： HPSEC法不能对注射用头孢他啶阿维巴坦钠的聚合物杂质进行有效质控，建立的RP-HPLC法分析注射用头孢他啶阿维巴坦钠聚合物杂质的专属性良好，样品中的聚合物杂质均来自头孢他啶，阿维巴坦钠不产生聚合物杂质。
, authors=李进, 姚尚辰, 尹利辉, 许明哲, 胡昌勤, authorsList=李进, 姚尚辰, 尹利辉, 许明哲, 胡昌勤, authorCompany=null, correspAuthors=许明哲, authorNote=
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李进，男，主任药师，主要从事抗生素药物的杂质谱研究。联系电话：（010）53851560，E-mail：medjinli@126.com。
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李进，男，主任药师，主要从事抗生素药物的杂质谱研究。联系电话：（010）53851560，E-mail：medjinli@126.com。
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