注射用头孢硫脒聚合物杂质分析  

Analysis of polymer impurities in Cefathiamidine for Injection

作　　者：崇小萌[1] 田冶[1] 姚尚辰[1] 尹利辉[1] 刘颖[1] 许明哲[1] CHONG Xiao-meng;TIAN Ye;YAO Shang-chen;YIN Li-hui;LIU Ying;XU Ming-zhe(National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《中国药学杂志》2021年第24期2008-2016,共9页Chinese Pharmaceutical Journal

摘　　要：目的建立专属性较好的注射用头孢硫脒中聚合物的分析方法。方法采用柱切换二维液相色谱系统将高效凝胶色谱系统与反相色谱系统相衔接,采用反相色谱系统对11个厂家的注射用头孢硫脒中聚合物进行分析。采用柱切换液-质联用方法对注射用头孢硫脒中聚合物进行定性分析。结果建立了可用于分析聚合物的反相液相色谱方法,在此色谱系统中,可实现对小分子杂质以及聚合物杂质进行同时分析的目的,专属性较好,并对其中6种聚合物杂质进行了定性分析。结论形成了注射用头孢硫脒中有关物质以及聚合物分析的方法策略,有助于比较不同厂家生产工艺控制的优劣。OBJECTIVE To establish an analytical method for polymers in cefathiamidine for injection with better specificity. METHODS High performance gel chromatography system was connected with HPLC system by column switching two-dimensional liquid chromatography system, using HPLC system to analyze the polymers in cefathiamidine for injection in 11 manufacturers. RESULTS A HPLC chromatography method for the analysis of polymers was established, in this chromatographic system, the simultaneous analysis of small molecular impurities and polymer impurities can be realized, this method was more specific, and 6 polymer impurities were qualitative analyzed. CONCLUSION The method and strategy of analysis of related substances and polymers in cefathiamidine for injection are formed, which is helpful to compare the advantages and disadvantages of different manufacturers′ production process control.

关 键 词：注射用头孢硫脒 头孢类聚合物杂质 柱切换液质联用 

分 类 号：R917[医药卫生—药物分析学]