Study on the determination of compound levonorgestrel sustained release microspheres injection by HPLC
10.3760/cma.j.cn101441-20230412-00152
- VernacularTitle:高效液相色谱法测定复方左炔诺孕酮缓释微球注射剂药物含量的研究
- Author:
Xingchen CAO
1
;
Yilin GUO
;
Chuncao ZHAO
;
Feng PAN
;
Jianxing CHEN
;
Fuzheng REN
;
Yan LIU
;
Linglin FENG
Author Information
1. 华东理工大学药学院 制药工程与过程化学教育部工程研究中心，上海 200237
- Publication Type:Journal Article
- Keywords:
Levonorgestrel;
Ethinyl estradiol;
High-performance liquid chromatography;
Compound sustained-release microspheres;
Content determination
- From:
Chinese Journal of Reproduction and Contraception
2024;44(3):300-303
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish a high-performance liquid chromatography (HPLC) for determining the content of levonorgestrel (LNG) and ethinylestradiol (EE) in compound levonorgestrel sustained-release microsphere injection.Methods:C18 column Inertsil ODS-3 (4.7 mm×250 mm, 5 μm) was used. The mobile phase was acetonitrile-water (50∶50, V/V). The flow rate was 1.0 mL/min. The column temperature was 35 ℃. The detection wavelength was 265 nm, and the injection amount was 20 μL. The content of microspheres was determined after validation of HPLC detection methodology.Results:The linear relationship was good in the range of 5.03-201.20 μg/mL LNG, 1.55-61.92 μg/mL EE ( r2=0.999 8). The specificity, precision, recovery, repeatability, stability, etc, met the requirements. The content of LNG in the compound LNG sustained-release microspheres injection was 16.26%, and the content of EE was 2.58%. Conclusion:This HPLC can determine the content of compound levonorgestrel sustained-release injection microspheres, and the method is simple, stable, and has good reproducibility, providing a reference for the determination of levonorgestrel and ethinylestradiol in compound sustained-release preparations.
