复方醋酸环丙孕酮片的溶出度测定

Dissolution test of cyproterone acetate tablets

目的建立准确测定复方醋酸环丙孕酮片溶出度的方法。方法以 0 .1mol/L盐酸溶液为介质 ,溶出平衡校正 ,酸碱中和 ,溶液直接注入液相色谱仪 ,分离 ,测定。结果重复进样 (n =6 )醋酸环丙孕酮和炔雌醇响应值的RSD值分别为 0 .4 %和1 5 %。线性范围 :醋酸环丙孕酮在 0 .2 831～ 2 .830 5 μg/mL浓度范围 ,炔雌醇在 0 .0 0 5 134～ 0 .0 5 1342 μg/mL浓度范围均呈良好线性关系 (r均为 0 .9999)。平均回收率 :醋酸环丙孕酮和炔雌醇分别为 10 0 .3% ,RSD =0 .7% ;99.7% ,RSD =3.5 %。结论本文方法简便。

Objective To establish an accurate method for dissolution test of cyproterone acetate tablets. Methods The dissolution was determined with HPLC by using 0.1 mol/L hydrochloric acid as solvent, due to the instability of ethinylestradiol in 0.1 mol/L hydrochloric acid, the correction and neutralization were needed for dissolution test. Results Chromatographs were obtained with six replicate injections of standard preparation. The relative standard deviation(RSD)of cyproterone acetate was 0.4% and ethinylestradiol was 1.5%. Linear concentration range of cyproterone acetate was 0.2831～2.8305 μg/mL, ethinylestradiol was 0.005134～0.051342 μg/mL. The average recovery of cyproterone acetate was 100.3%,ethinylestradiol was 99.7%,with RSD 0.7% and 3.5% respectively. Conclusion The method is simple and accurate.