药物中磺酸酯类基因毒性杂质测定方法研究进展  

Research progress in the determination of genotoxic impurities of sulfonates

作　　者：韩佳芮 徐艳梅 郝丽娟 高燕霞 HAN Jiarui;XU Yanmei;HAO Lijuan;GAO Yanxia(Hebei University of Science and Technology,Shijiazhuang 050091,China;Hebei Institute for Drug and Medical Device Inspection,Shijiazhuang 050200,China)

机构地区：[1]河北科技大学,石家庄050091 [2]河北省药品医疗器械检验研究院,石家庄050200

出　　处：《化学分析计量》2023年第6期104-108,共5页Chemical Analysis And Meterage

基　　金：中央引导地方科技发展资金项目(216Z4802G)。

摘　　要：介绍磺酸酯类基因毒性杂质的分析方法,包括高效液相色谱法、液相色谱-质谱联用法、气相色谱法和气相色谱-质谱联用法等。高效液相色谱法操作简单,应用广泛,能实现绝大多数化合物的分离、分析;液相色谱-质谱联用法具有灵敏度高、准度高、特异性高等特点;气相色谱应用于易分离气体和易挥发的成分的检测,灵敏度高,专属性强;气相色谱-质谱联用法具有分析速度快、分离效能好、灵敏度高、选择性强的特点。开发通用、简便、灵敏度高的分析检测方法,为更好地监测磺酸酯类基因毒性杂质提供理论参考。The analytical methods of genotoxic impurities of sulfonates were introduced,including high performance liquid chromatography,liquid chromatography-mass spectrometry,gas chromatography and gas chromatography-mass spectrometry.High performance liquid chromatography was simple to operate and widely applied,and could realize the separation and analysis of most compounds.Liquid chromatography-mass spectrometry had the characteristics of high sensitivity,high accuracy and high specificity.Gas chromatography was used in the detection of easily separated gases and volatile components,with high sensitivity and specificity.Gas chromatography-mass spectrometry had the characteristics of fast analysis speed,good separation efficiency,high sensitivity and strong selectivity.A general,simple and sensitive assay method was developed to provide theoretical reference for better monitoring of genotoxic impurities of sulfonates.

关 键 词：磺酸酯类 基因毒性杂质 分析方法 研究进展 

分 类 号：O657[理学—分析化学]