季铵盐类相转移催化剂残留于药物中的分析方法研究进展

Research Progress on Analytical Methods of Residual Quaternary Ammonium Salts as Phase Transfer Catalyst in Drug Substances

人用药品注册技术要求国际协调会(ICH)组织文件中明确指出需要对原料药生产过程中可能存在的催化剂进行控制和界定。季铵盐类相转移催化剂作为药物合成中的常用催化剂,其在药物中残留的分析方法越来越受到关注。本文综述了近年来季铵盐类物质的分析方法,包括气相色谱法、高效液相色谱法和离子色谱法等。

International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use （ICH） explicitly points out that it is necessary to control and define the residual quaternary ammonium salts in active pharmaceutical ingredients （APIs）. Quaternary ammonium salts are commonly used as phase transfer catalyst in the drug synthesis and people pay more and more attention to their analytical methods. Several analytical methods are reviewed in this paper, including gas chromatography, high-performance liquid chromatography, ion chromatography, etc.