Article(id=1236696519517197004, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236696515473895464, 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=1658937600000, acceptedDateStr=2022-07-28, onlineDate=1772781026963, onlineDateStr=2026-03-06, pubDate=1673712000000, pubDateStr=2023-01-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772781026963, onlineIssueDateStr=2026-03-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772781026963, creator=13701087609, updateTime=1772781026963, updator=13701087609, issue=Issue{id=1236696515473895464, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='1', pageStart='1', pageEnd='109', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1772781025999, creator=13701087609, updateTime=1772782685740, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236703476982542786, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236696515473895464, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236703476982542787, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236696515473895464, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=72, endPage=79, ext={EN=ArticleExt(id=1236696520133759698, articleId=1236696519517197004, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Analysis of polymer impurities in ceftizoxime sodium for injection, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

Objective: To establish a method for controlling polymer impurities in ceftizoxime sodium for injection. Methods: Ceftizoxime sodium was dissolved in phosphate buffer solution (pH 7.0) to prepare degradation solution. High performance size exclusion chromatography (HPSEC) and column switching-LC/MSn (CS-LC/MSn) were applied to separate and deduce the poor retention impurities in the degradation solution. The specificity of developed HPSEC method was evaluated. A RP-HPLC method for polymer analysis was established with a Phenomenex Gemini C₁₈ column, using phosphate buffer solution (pH 7.0)-acetonitrile as mobile phase under a gradient elution program. The specificity of RP-HPLC method was assessed by two-dimensional chromatography (2D-HPLC) and CS-LC/MSn, and LLOD and LLOQ were also tested. Results: ceftizoxime dimer and the dimer's isomer were deduced in the degradation solution as well as 6 small molecular impurities. Polymer impurities were liable to co-elute with small molecular impurities by HPSEC method, which made a poor quantification accuracy and specificity. Ceftizoxime dimer and the dimer's isomer were detected by RP-HPLC with a sufficient specificity. Conclusion: HPSEC method was not suitable for the quality control of polymer impurities in ceftizoxime sodium for injection, while the RP-HPLC method was specific, which can be applied for polymer impurities. Ceftizoxime degradation solution can be used to identify polymer peaks as the systematic suitability testing solution.

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目的：建立注射用头孢唑肟钠聚合物杂质的分析方法。方法：采用pH 7.0磷酸盐溶液为溶剂，制备头孢唑肟钠降解溶液；采用高效分子排阻色谱法（HPSEC）和柱切换-液质联用法（CS-LC/MSn），对头孢唑肟钠降解溶液的弱保留值杂质进行分离和结构推定，评估HPSEC法分析聚合物杂质的专属性；采用Phenomenex Gemini C₁₈色谱柱，以pH 7.0磷酸盐缓冲液-乙腈为流动相进行梯度洗脱，建立头孢唑肟钠聚合物的反相-高效液相色谱法（RP-HPLC），采用二维色谱法（2D-HPLC）和CS-LC/MSn法对其专属性进行分析，并测定了方法的定性限和定量限。结果：在头孢唑肟钠降解溶液中推定出头孢唑肟二聚体、二聚体异构体以及6种小分子杂质；HPSEC法分离头孢唑肟钠聚合物杂质时，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法分析头孢唑肟聚合物杂质时，能够检出头孢唑肟二聚体、二聚体异构体，专属性好。结论：HPSEC法不能对注射用头孢唑肟钠的聚合物杂质进行有效质量控制，建立的RP-HPLC法分析注射用头孢唑肟钠聚合物杂质的专属性良好，可将头孢唑肟钠降解溶液作为聚合物杂质系统适用性溶液。

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李进，男，博士，主任药师，研究方向：抗生素药物分析。E-mail: medjinli@126.com。

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李进，男，博士，主任药师，研究方向：抗生素药物分析。E-mail: medjinli@126.com。

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