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2021, v.31(12) 922-926+931

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头孢丙烯制剂中聚合物杂质分析方法的探索
Exploring the Analysis Method of Polymer Impurities in Cefprozil Products

杜玮炜;赖烨才;
DU Weiwei;LAI Yecai;Baiyunshan Pharmaceutical General Factory, Guangzhou Baiyunshan Pharmaceutical Holdings Co., Ltd.;Guangzhou BaiYunShan Pharmaceutical General Factory/Key Laboratory of Key Technology Research on Chemical Raw Materials and Preparations of Guangdong Province;

摘要(Abstract):

目的建立头孢丙烯制剂中聚合物杂质的分析方法。方法分别采用高效凝胶色谱法和反相高效液相色谱法,建立头孢丙烯系列制剂中的聚合物杂质检测方法,采用液质联用技术(LC/MS)对两种方法的检出能力和专属性进行比较,并对检出的杂质进行结构鉴定;比较头孢丙烯分散片、颗粒、片剂、干混悬剂4种制剂中的聚合物杂质含量。结果在头孢丙烯制剂中鉴定出2个高分子杂质,分别为头孢丙烯USP杂质I和头孢丙烯二聚体;高效凝胶色谱法分离头孢丙烯聚合物杂质时,易受小分子杂质的干扰,专属性不佳;反相色谱法梯度洗脱中聚合物杂质出峰集中,在20~23 min范围内能有效检出头孢丙烯所有聚合物杂质;头孢丙烯4种制剂中的聚合物杂质含量相当。结论高效凝胶色谱法不能对头孢丙烯制剂中的聚合物杂质进行有效的控制,建立的反相高效液相色谱法可检出所有聚合物杂质,方法专属性符合要求,可有效控制产品聚合物杂质。
OBJECTIVE To establish a method for the determination of polymer impurities in cefprozil products. METHODS HPSEC and RP-HPLC were used to separate and identify the polymer impurities in cefprozil products. LC/MS method was used to compare the detection ability and specificity of the two methods, and the structure of the detected impurities were identified. The content of the polymer impurities in the four products of cefprozil(cefprozil dispersible tablets, cefprozil granules, cefprozil tablets, cefprozil for oral suspension) were compared. RESULTS Two impurities with high molecular weight were identified in cefprozil products, which were cefprozil USP impurity I and cefprozil dimer. Polymer impurities were liable to co-elute with small molecular impurities, which made a poor specificity of HPSEC method. In the gradient elution of RP-HPLC method, the polymer impurities were concentrated, and all polymer impurities of cefprozil were detected in the range of 20-23 min. The contents of polymer impurities in the four cefprozil products were almost the same. CONCLUSION HPSEC can not suitable for the control of polymer impurities in cefprozil products. The established RP-HPLC method can be applied to identify all the polymer impurities, which fulfill the requirement of specificity. And the polymer impurities content can be controlled effectively.

关键词(KeyWords): 聚合物;高效凝胶色谱法;反相高效液相色谱法;液质联用;头孢丙烯
polymer;HPSEC;RP-HPLC;LC/MS;cefprozil

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基金项目(Foundation): 广东省基础与应用基础研究基金项目(2020A1515111195)

作者(Author): 杜玮炜;赖烨才;
DU Weiwei;LAI Yecai;Baiyunshan Pharmaceutical General Factory, Guangzhou Baiyunshan Pharmaceutical Holdings Co., Ltd.;Guangzhou BaiYunShan Pharmaceutical General Factory/Key Laboratory of Key Technology Research on Chemical Raw Materials and Preparations of Guangdong Province;

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