注射用克林霉素磷酸酯质量分析

Quality analysis of clindamycin phosphate for injection

目的 评价国内注射用克林霉素磷酸酯的质量,并对质量标准进行完善。方法 采用法定检验方法与探索性研究相结合,对2021年国家药品抽验得到的142批次样品进行比较分析。结果 按法定标准检验142批次样品的合格率为100%。但现行法定标准存在“一药多标”现象,且有关物质方法设置不合理,限度不同,含量测定方法待改进等问题。探索性研究新建了有关物质和含量测定法,并采用LC/MS等方法确证了各杂质的结构,并对杂质的来源进行归属。结论 目前国内注射用克林霉素磷酸酯总体质量良好,但存在杂质随着贮存时间的延长,含量明显增加的问题;此外法定检验标准未对含量最大的杂质B和F进行控制,法定标准有待统一和提高。

Objective To evaluate the quality of clindamycin phosphate for injection and improve the quality standards. Methods The statutory standard method combined with exploratory researches were used to evaluate the quality of 142 batches clindamycin phosphate for injection. Results According to the statutory standards, the qualifi ed rate of the 142 batches was 100%. But the current standards were not consistent. There were some problems, such as unreasonable setting of material gradient, disunity of limit, and infeasible determination method of assay. A new method of related substances was established, and the source and the structures of some impurities were identifi ed by LC/MS. Conclution The quality of clindamycin phosphate for injection was good, but the impurity content increased obviously with the extension of storage time. The statutory standards do not control the largest of impurities B and F. The statutory standards need to be unifi ed and improved.