Analysis Method of Empagliflozin and Related Substances in Empagliflozin Bulk Drug and Tablets
10.3870/j.issn.1004-0781.2025.01.003
- VernacularTitle:恩格列净原料及片剂有关物质的检查方法
- Author:
Yanlin HE
1
;
Ying XIA
;
Chaoyu HUANG
;
Hongyu FAN
;
Jialiang ZHU
;
Rui LI
;
Geng LI
;
Fei YAN
Author Information
1. 中国药科大学药物分析教研室,南京 210009
- Publication Type:Journal Article
- Keywords:
Empagliflozin;
Related substances;
Liquid chromatography;
Full factorial design;
Box-Behnken model
- From:
Herald of Medicine
2025;44(1):24-31
- CountryChina
- Language:Chinese
-
Abstract:
Objective To establish a high-performance liquid chromatography method to detect empagliflozin and related substances in empagliflozin bulk drug and tablets,and to provide technical support for quality control and unified monitoring of empagliflozin bulk drug and its tablets.Methods A liquid chromatography development system with the full factorial design of experiments and the Box-Behnken model was used to screen and optimize the chromatographic parameters.Related substances were detected in empagliflozin API and empagliflozin tablets from different companies with the optimized chromatographic parameters.Results The optimized chromatographic parameters were obtained:Shim-pack GIST C18-AQ column(250 mm×4.6 mm,5 μm)was used,column temperature was 15 ℃,gradient elution with water-acetonitrile as mobile phase was as below,flow rate was 1.2 mL·min-1,detection wavelength was set at 224 nm.The specificity of the method is good,with recoveries ranging from 94.8％to 101.7％,and RSD ranging from 0.5％to 3.1％.The known single impurity in APIs and tablets is less than 0.05％,any other unknown single impurity is less than 0.06％,and the total amount of impurities are less than 0.3％.The related substances of supervised sampling are under good control.Conclusion The method is reliable and robust for determining related substances of empagliflozin and its tablets.
