中国药典2020年版药用辅料二丁基羟基甲苯质量标准有关物质检查修订建议  

Revision suggestion for relevant substance testing of the Chinese Pharmacopoeia 2020 of the quality standard of dibutylhydroxytoluene for pharmaceutical excipients

作　　者：韩蓓 胡琴 张喆 王铁松 吴科春 戴红 HAN Bei;HU Qin;ZHANG Zhe;WANG Tiesong;WU Kechun;DAI Hong(Beijing Institute For Drug Control,NMPA Key Laboratory of Generic Drug Research and Evaluation,Beijing 102206,China)

机构地区：[1]北京市药品检验研究院国家药品监督管理局仿制药研究与评价重点实验室,北京102206

出　　处：《中国药品标准》2023年第2期194-199,共6页Drug Standards of China

基　　金：国家药典委员会药品标准制修订研究课题(2019Y041)。

摘　　要：目的:针对《中国药典》2020年版四部二丁基羟基甲苯质量标准中有关物质检查项方法专属性差、重复性不强、耗时较长等问题,建立其有关物质测定的高效液相色谱法,对该辅料质量标准进行修订。方法:对USP43方法进行了优化,将薄层色谱法检查有关物质修订为高效液相色谱法,并进行方法学验证。结果:按修订后方法进行有关物质检查,9种指定杂质具有良好分离度,4批样品均符合规定。结论:修订后有关物质检查方法操作简单,灵敏度高,实验结果准确可靠,可替代《中国药典》2020年版四部二丁基羟基甲苯质量标准现有有关物质检查方法。Objective:In view of the problems of poor specificity,poor repeatability,and long time consumption of related substances in the quality standards of the four dibutylhydroxytoluene quality standards of the 2020 edition of the Chinese Pharmacopoeia,a high-performance liquid chromatography method for the determination of related substances was established.In order to revise the quality standard of this excipient.Methods:The USP43 method was optimized,and the TLC method for related substances testing was revised to high performance liquid chromatography,and the method was verified.Results:The inspection of related substances was carried out according to the revised method,and the 9 designated impurities had good separation degree,and the 4 batches of samples were all in compliance with the regulations.Conclusion:The revised testing method for related substances is simple in operation,high in sensitivity,accurate and reliable in experimental results,and can replace the existing methods for related substances testing in the 2020 edition of the Chinese Pharmacopoeia,Part Four of the Quality Standards for Dibutylhydroxytoluene.

关 键 词：二丁基羟基甲苯 有关物质 中国药典 质量标准修订 高效液相色谱 

分 类 号：R921.2[医药卫生—药学]