Article(id=1236689047129739671, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236689043514257626, 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=1662134400000, acceptedDateStr=2022-09-03, onlineDate=1772779245407, onlineDateStr=2026-03-06, pubDate=1680105600000, pubDateStr=2023-03-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772779245407, onlineIssueDateStr=2026-03-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772779245407, creator=13701087609, updateTime=1772779245407, updator=13701087609, issue=Issue{id=1236689043514257626, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='6', pageStart='553', pageEnd='656', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1772779244545, creator=13701087609, updateTime=1772779562627, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236690377705575144, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236689043514257626, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236690377705575145, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236689043514257626, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=629, endPage=637, ext={EN=ArticleExt(id=1236689048207675805, articleId=1236689047129739671, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Analysis of polymer impurities in penicillin 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 penicillin sodium for injection.
Methods: Penicillin sodium was dissolved by water to prepare penicillin polymer stock solution. High performance size exclusion chromatography method (HPSEC) and column switching-LC/MSn method were used to separate and deduce the weak retention impurities in polymer impurity solution and the specificity of HPSEC method was evaluated. A RP-HPLC method for polymer analysis was established with a C18 column, using gradient elution by the mixed solution [phosphate buffer solution (pH 3.4)-methanol (72∶14)] and acetonitrile, and the RP-HPLC method was validated.
Results: 4 polymers, their isomers, one dimer degradation and some small molecular impurities were identified in the polymer impurity solution. Polymer impurities were liable to be co-eluted with small molecular impurities by HPSEC method, which resulted in poor quantification accuracy and specificity. 3 indicative polymer impurities were detected by RP-HPLC method with effective specificity, including 2 dimers produced by different polymerized patterns.
Conclusion: HPSEC cannot effectively control the polymer impurities of penicillin sodium for injection. The established RP-HPLC method has good specificity and high sensitivity for the determination of impurities in penicillin sodium polymer for injection.
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目的： 建立注射用青霉素钠中聚合物杂质的分析方法。
方法： 采用水为溶剂制备青霉素钠的聚合物杂质溶液；采用高效分子排阻色谱法（HPSEC）和柱切换-LC/MSn法对聚合物杂质溶液的弱保留值杂质进行分离和结构鉴定，并评估高效凝胶色谱法分析聚合物杂质的专属性；采用C18型反相色谱柱，以［磷酸盐缓冲液溶液（pH 3.4）-甲醇（72∶14）］-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： 在聚合物杂质溶液中鉴定出4种青霉素聚合物及其异构体，1种二聚体降解物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，定量准确性与方法专属性差；RP-HPLC法分析能够检出3个指针性青霉素钠聚合物杂质峰，其中包含2种不同聚合方式形成的二聚体杂质。
结论： HPSEC法不能对注射用青霉素钠的聚合物杂质进行有效质控，建立的RP-HPLC法分析注射用青霉素钠聚合物杂质的专属性良好、灵敏度高。
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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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