Quantitative Analysis of Mifepristone Binary Mixed Crystal System Based on Infrared Spectroscopy
10.3870/j.issn.1004-0781.2025.06.009
- VernacularTitle:基于红外光谱技术米非司酮二元混晶体系定量分析
- Author:
Jian ZHOU
1
;
Shiying YANG
1
;
Li ZHANG
1
;
Lianhua FANG
1
;
Guanhua DU
1
;
Yang LYU
1
Author Information
1. 中国医学科学院·北京协和医学院药物研究所脑血管病新药发现及晶型研究北京市重点实验室,北京 100050
- Publication Type:Journal Article
- Keywords:
Mifepristone;
Polymorphism;
Infrared spectroscopy;
Quantitative analysis
- From:
Herald of Medicine
2025;44(6):894-899
- CountryChina
- Language:Chinese
-
Abstract:
Objective The quantitative analysis model of mifepristone binary mixed crystal system was established by infrared spectroscopy to improve the quality control level of Mifepristone raw material.Methods Two mifepristone polymorphs samples were prepared and characterized,and the quantitative analysis model of infrared spectral data was constructed by classical linear regression method and chemometrics method respectively.On this basis,the influence of different factors on the model quality was investigated comprehensively.Results Infrared spectroscopy combined with classical linear regression method and stoichiometric method can build a quantitative analysis model for binary mifepristone polymorphs system,and the model has good linear regression coefficient(R2)and root mean square error of cross validation(RMSECV)values.Conclusions The two polymorphs of mifepristone have independent infrared spectral characteristic peaks that can be used for quantitative study,so the classical linear regression method has more significant methodical advantages for this system.The chemometrics method is more suitable for the quantitative study of complex mixed polymorphs system.
