Study on the determination of compound levonorgestrel sustained release microspheres injection by HPLC
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.
NETL
NSTL
万方数据
