复方左炔诺孕酮片和滴丸含量及含量均匀度测定___

Objective:To establish an HPLC method for determination of assay of ethinylestradiol and levonorgestrel in compound levonorgestrel tablets and its pills,as well as to investigate their content uniformity.Methods: Using Waters Symmetry 300^TM C₁₈ column(4.6 mm×150 mm,5 μm),the mobile phase was acetonitrile-water(40∶60) at a flow rate of 1.0 mL·min^-1 and detection wavelength was 220 nm.Results:The linear ranges of ethinylestradiol and levonorgestrel were 1.554-31.08 μg·mL^-1(r=0.9999) and 7.549-151.0 μg·mL^-1 respectively(r=0.9999).The average recoveries(n=3) of ethinylestradiol and levonorgestrel of compound levonorgestrel tablets were 99.6%-101.8% with RSD of 0.55%-1.2% and 99.5%-100.7% with RSD of 0.46%-1.6%;The average recoveries(n=3) of ethinylestradiol and levonorgestrel of compound levonorgestrel pills were 100.6%-101.1% with RSD of 0.92%-1.8% and 97.9%-98.7% with RSD of 1.1%-1.9%.The content uniformities of compound levonorgestrel pills were good,but some of compound levonorgestrel tablets were not complied with the standard of Chinese Pharmacopoeia 2005 edition.Conclusion:The HPLC method is good in the aspect of selectivity and sensitivity,the HPLC method can be applicable for the determination of assay and content uniformity of compound levonorgestrel tablets and its pills.In order to safe and effectively use estrogen contraceptive,we have to control the quality of contraceptive in common used in China.

1 ChP(中国药典).2005 Vol Ⅱ(二部)：424