Study of Related Substances and Impurity Profiles of Ornidazole Active Pharmaceutical Ingredient and Injection Based on National Drug Sampling and Testing
10.3870/j.issn.1004-0781.2025.10.010
- VernacularTitle: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
- Author:
Qingqing ZHANG
1
;
Xiaodie HE
;
Qing HUANG
;
Yue GENG
;
Minwen HUANG
;
Minhui CHEN
;
Jialiang ZHU
Author Information
1. 江苏省药品监督检验研究院化学药品检验二室,南京 210019
- Publication Type:Journal Article
- Keywords:
Ornidazole;
Related substances;
Impurity profile;
Liquid chromatography-tandem mass spectrometry
- From:
Herald of Medicine
2025;44(10):1580-1587
- CountryChina
- Language:Chinese
-
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.
