医药导报2025，Vol.44Issue(10)：1580-1587,8.DOI:10.3870/j.issn.1004-0781.2025.10.010
基于国家药品抽检奥硝唑原料药及注射液有关物质及杂质谱研究
Study of Related Substances and Impurity Profiles of Ornidazole Active Pharmaceutical Ingredient and Injection Based on National Drug Sampling and Testing
摘要
Abstract
Objective To determine the related substances in ornidazole active pharmaceutical ingredient(API)and injections using high performance liquid chromatography(HPLC)and to study the impurity profile of ornidazole using liquid chromatography-tandem mass spectrometry(LC-MS/MS)combined with forced degradation tests,aiming to clarify the sources of impurities and their correlation with the prescription and production process and providing technical support for the unified evaluation and quality control of this product.Methods A Phenomenex Luna C18column(4.6 mm×250 mm,5 μm)was used for the separation of ornidazole and its impurities,with 0.000 5%formic acid as mobile phase A and methanol as mobile phase B under gradient elution.The impurity content of 4 batches of APIs,3 batches of reference preparations,and 11 batches of domestic generic preparations were determined.The structure of unknown impurities was predicted using Jet Stream Ion Focusing Electrospray Ionization-Time of Flight Mass Spectrometry(AJS-TOF-MS/MS),and the sources of impurities were identified combined with forced degradation experiments,the prescription and the production process of various manufacturers.Results Ornidazole and its known impurities were well separated under the chromatographic conditions.The structures of five unknown impurities were inferred,and the sources of the impurities were identified.Conclusion This study provides a reference for impurity analysis,quality control,and overall evaluation of ornidazole API and injection.关键词
奥硝唑/有关物质/杂质谱/液相色谱-质谱联用技术Key words
Ornidazole/Related substances/Impurity profile/Liquid chromatography-tandem mass spectrometry分类
医药卫生引用本文复制引用
张青青,何晓蝶,黄青,耿悦,黄敏文,陈民辉,朱嘉亮..基于国家药品抽检奥硝唑原料药及注射液有关物质及杂质谱研究[J].医药导报,2025,44(10):1580-1587,8.基金项目
国家药品抽检计划(1号文) （1号文）
江苏省药品监督管理局科研计划项目(202317). （202317）
