文章摘要
韩蓓,胡琴,张喆,王铁松,吴科春,戴红.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[J].中国药品标准,2023,24(2):
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
Some Suggestions on Revision of the Quality Standards of Pharmaceutical Excipient Butylated Hydroxytoluene in Chinese Pharmacopoeia Volume IV (2020 Edition)
投稿时间:2022-06-21  修订日期:2023-04-04
DOI:
中文关键词: 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
英文关键词: Butylated Hydroxytoluene, related substances, ChP, revision of quality standards, HPLC
基金项目:
作者单位E-mail
韩蓓 北京市药品检验研究院 terryjordan@163.com 
胡琴 北京市药品检验研究院  
张喆 北京市药品检验研究院  
王铁松 北京市药品检验研究院  
吴科春* 北京市药品检验研究院 wukechun@bidc.org.cn 
戴红 北京市药品检验研究院  
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中文摘要:
      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采用的薄层色谱法专属性差、重复性不强、耗时较长等问题,建立有关物质测定的高效液相色谱分析方法,对该辅料质量标准进行修订。方法: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。
英文摘要:
      Abstract Objective: To put forward some practical revising suggestions on the Butylated Hydroxytoluene (BHT) quality in Chinese pharmacopoeia(2020 Edition) focusing on the problems of poor specificity, low repeatability and long time-consuming. Methods: Change the substance-based quantitative method from thin-layer chromatography to the high performance liquid chromatography(HPLC), the chromatographic conditions of the related substances were established, and method validation was carried out. Results: Using the improved method to determine the related substances of BHT, 9 known impurities had a good degree of separation,the results of 4 batches of samples are qualified. Conclusion: The improved method is accurate and feasible. It provided a reference for revising the quality standards of 2,6-Di-tert-butyl-4-methylphenol in the 2020 edition of Chinese Pharmacopoeia.
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