盐酸二甲双胍药物中杂质测定方法研究进展

Progress in the determination of impurities in metformin hydrochloride drugs

对近年来盐酸二甲双胍类药物中杂质的测定方法进行综述。盐酸二甲双胍类药物中的杂质主要有双氰胺、二甲胺以及由二甲胺形成的亚硝胺类基因毒性杂质等。测定方法主要有高效液相色谱(HPLC)法、离子色谱(IC)法、高效液相色谱-串联质谱(HPLC-MS/MS)法和气相色谱-串联质谱(GC-MS/MS)法,其中高效液相色谱法主要用于测定双氰胺,衍生化-高效液相色谱法和离子色谱法主要用于测定二甲胺,HPLC-MS/MS法和GC-MS/MS法主要用于测定亚硝胺类基因毒性杂质。该综述旨在为盐酸二甲双胍类药物中杂质的测定提供参考。

The determination methods of impurities in metformin hydrochloride in recent years were reviewed. The impurities in metformin hydrochloride drugs mainly including dicyandiamide, dimethylamine residues and nitrosamine genotoxic impurities formed by dimethylamine. The determination methods mainly including high performance liquid chromatography(HPLC), ion chromatography(IC), high performance liquid chromatography-tandem mass spectrometry(HPLC-MS/MS) and gas chromatography-tandem mass spectrometry(GC-MS/MS). Among them, HPLC was mainly used for the determination of dicyandiamide, derivatization-HPLC and IC were mainly used for the determination of dimethylamine, HPLC-MS/MS and GC-MS/MS were mainly used for the determination of nitrosamine genotoxic impurities. The review aims to provide reference for the determination of impurities in metformin hydrochloride drugs.