Research on Analysis Method of Ketoconazole Related Substancse Based on National Drug Sampling and Testing
10.3870/j.issn.1004-0781.2025.10.015
- VernacularTitle:基于国家药品抽检的酮康唑有关物质检查方法研究
- Author:
Changying XIN
1
;
Yanbin XUN
;
Xinying YU
;
Yu HAN
;
Qiong WU
;
Longshan ZHAO
;
Liqun LIU
;
Jialiang ZHU
Author Information
1. 黑龙江省药品检验研究院,哈尔滨 150088;沈阳药科大学,沈阳 110016
- Publication Type:Journal Article
- Keywords:
Ketoconazole;
Related substancse;
Gentoxic impurities;
National drug sampling and testing;
High performance liquid chromatography
- From:
Herald of Medicine
2025;44(10):1611-1617
- CountryChina
- Language:Chinese
-
Abstract:
Objective To establish the HPLC analysis method for ketoconazole related substances,and to provide technical support for the improvement of the quality standard and the purity of ketoconazole.Methods Gradient elution conditions were optimized based on the chromatographic parameters outlined in the 2024"British Pharmacopoeia"for ketoconazole cream.A C18 column(4.6 mm×150 mm,3 μm)was used to facilitate the elution process using a gradient of acetonitrile and acetate buffer,and detection performed at a wavelength of 230 nm.Results The known impurities and potentially genotoxic impurities in the material drugs of ketoconazole can be more effectively separated using the established methods,which are both robust and highly sensitive.The content of the two potentially geno toxic impurities,six known impurities and unknown impurities in the 21 batches of ketoconazole sourced from five raw material pharmaceutical companies is below the specified limit requirements.Conclusion This method contributes to improving the quality of ketoconazole ingredients,ensuring the safety of ketoconazole preparations,and better supporting the regulatory supervision.
