摘要
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.
作者
徐艳梅
卞广利
高辉
王俊峰
王振刚
高燕霞
XU Yanmei;BIAN Guangli;GAO Hui;WANG junfeng;WANG Zhengang;GAO Yanxia(Hebei Provincial Institute of Drug and Medical Device Inspection,Shijiazhuang 050200,China;The Second Hospital of Hebei Medical University,Shijiazhuang 050000,China;Shijiazhuang Huaxin Pharmaceutical Co.,Ltd.,Shijiazhuang 050000,China;Hebei Tiancheng Pharmaceutical Co.,Ltd.,Cangzhou 061000,China)
出处
《化学分析计量》
CAS
2022年第3期95-99,共5页
Chemical Analysis And Meterage
基金
河北省市场监督管理局科研计划项目(2021YJ10)。
关键词
盐酸二甲双胍
双氰胺
二甲胺
基因毒性杂质
综述
metformin hydrochloride
dicyandiamide
dimethylamine
genotoxic impurities
overview