复方醋酸环丙孕酮片的溶出度测定
复方醋酸环丙孕酮片,,复方醋酸环丙孕酮片;溶出度；测定,1仪器与试药,2方法与实验,3讨论,参考文献
摘 要 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0.1 mol/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15%。线性范围：醋酸环丙孕酮在0.2831~2.8305 μg/mL浓度范围，炔雌醇在0.005134~0.051342 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100.3%，RSD=0.7%；99.7%，RSD=3.5%。结论 本文方法简便、准确。关键词 复方醋酸环丙孕酮片;溶出度；测定
Dissolution test of cyproterone acetate tablets
HU Jiachi, LI Qiaoming
(Guangzhou Institute for Drug Control, Guangzhou 510160，China)
Abstract 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% ......
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