复方醋酸甲地孕酮片溶出度检测

Detection of Dissolution of Compound Megestrol Acetate Tablets

目的对复方醋酸甲地孕酮片溶出过程进行评价。方法采用桨法,转速75r·min-1,以pH 1.2盐酸溶液、pH 4.0醋酸盐缓冲液、pH 6.8磷酸盐缓冲液和0.5%十二烷基硫酸钠溶液为溶出介质;采用HPLC法测定,Agela Venusil XBP C18(L)色谱柱(4.6 mm×250 mm,5μm),流动相:乙腈-水(57∶43),流速:1.0mL·min-1,柱温:30℃,进样量:100μL。醋酸甲地孕酮采用紫外检测器,检测波长:288nm;炔雌醇采用荧光检测器,激发波长:285nm,发射波长:310nm。结果与结论3批次制剂中低组分炔雌醇溶出曲线与参比制剂不相似,醋酸甲地孕酮溶出曲线相似。

Objective To evaluate the dissolution process of compound megestrol acetate tablets. Methods The dissolution process of compound megestrol acetate tablets was determined by HPLC with paddle method.The pH 1.2 hydrochloric acid solution,the pH 4.0 acetate buffer solution,the pH 6.8 phosphate buffer and the 0.5% sodium lauryl sulfate solution were used as dissolution mediums.The rotation rate of paddle was 75r·min-1.The Agela Venusil XBP C18（L）column（4.6mm×250mm, 5μm）and the mobile phase of acetonitrile-water（57∶43）were used at the flow rate of 1.0mL·min-1. The detection wavelength was 288nm for UV detector for megestrol acetate,an excitation wavelength 285nm and an emission wavelength 310nm for spectrofluorometric detector for ethinyl estradiol.The column temperature was 30℃ and the injection volume was 100μL.Results and Conclusion Among the 3 batches of preparations,the dissolution curves of ethinyl estradiol and reference preparations were not similar,while those of megestrol acetate tablets and reference preparations were similar.