注射用头孢硫脒聚合物检测方法比较及聚合物杂质分析

Comparison of different polymer detection methods and analysis of polymer impurities of cefathiamidine for injection

目的:本研究采用不同的方法对注射用头孢硫脒中聚合物杂质进行分析,比较不同方法专属性的优劣。方法:分别采用葡聚糖凝胶G10系统、高效凝胶色谱系统以及柱切换液质联用系统对11个厂家的注射用头孢硫脒中聚合物进行分析。结果:葡聚糖凝胶G10系统并未检出聚合物,高效凝胶色谱系统可检出聚合物,采用柱切换液质联用方法对高效凝胶色谱系统分离的组分进行了结构确认。结论:柱切换液质联用方法证明了注射用头孢硫脒中存在多种聚合物杂质,葡聚糖凝胶G10系统以及高效凝胶色谱系统专属性较差,无法将大分子聚合物和小分子杂质进行分离和定性,为进一步建立专属性更好的方法奠定了基础。

Objective: To analyze polymer impurities in cefathiamidine for injection by different methods, and compare the advantages and disadvantages of the specificity of different methods. Methods: By using Sephadex G-10 System, high performance gel chromatography and column switching-LC-MSn method, the polymers in cefathiamidine for injection from 11 manufacturers were analyzed. Results: No polymer was detected by Sephadex G10 System, high performance gel chromatography could detect polymer impurities, the structure of the components separated by high performance gel chromatography system was confirmed by the column switching-LC-MSn method. Conclusion: It was proved that there were some polymer impurities in cefathiamidine for injection, the Sephadex G10 System and high performance gel chromatography had poor specificity, and macromolecular polymers and small molecular impurities could not be separated and qualitatively analyzed. This study laid the foundation to further establish a better specificity method.