RP-HPLC法测定三相避孕片含量和含量均匀度的研究

STUDIES ON THE QUANTITATION AND UNIFORMITY OF DOSAGE UNITS OF TRIPHASE CONTRACEPTIVE TABLETS BY RP HPLC

建立的三相避孕片的反相高效液相色谱测定法，能同时测定炔雌醇和左旋甲基炔诺酮的含量。 用 Ｃ１８ 柱，检测波长 ２２０ｎｍ ，流动相为甲醇水（７０∶３０）。炔雌醇的回收率为 ９９．５３％ ， Ｒ Ｓ Ｄ 为１１５％ ，左旋甲基炔诺酮的回收率为 ９９７１％ ， Ｒ Ｓ Ｄ 为 １８７％ 。该方法准确、灵敏、简便、快速。

An RP HPLC method for the simultaneous determination of ethinyl estradiol and levonorgestrel in triphase contraceptive tablets was estalished, the method was also applied in its uniformity of dosage units study. Using Shimpack CLC ODS(4.6 mm×150 mm) column with methanol water (70∶30) as mobile phase, detection UV 220 nm. The recovery was 99.53%( RSD was 1 15%) and 99.71( RSD was 1.87%) for ethinyl estradiol and levonorgestrel, respectively. The established method was proved to be rapid, sensitive and have a good reproducibility.