Dissolution detection of desogestrel and ethinylestradiol tablets by HPLC / 国际药学研究杂志

ABSTRACT

Objective To develop a HPLC method for determining the dissolution of desogestrel and ethinylestradiol tablets. Methods The dissolution was determined by the second method described in Chinese Pharmacopoeia (ChP) 2015. In total 500 ml of 0.05% sodium lauryl sulfate solution was used as dissolution media, and the rotation speed was 50 r/min. The dissolution time was 30 min and the dissolution was determined by HPLC. The HPLC column was Agilent SB C18 column (150 mm×4.6 mm, 5 µm). The mobile phase acetonitrile as mobile phase A, acetonitrile-water (5050, V/V) as mobile phase B with gradient elution. The flow rate was 1 ml/min. The detection wavelength of desogestrel and ethinylestradiol was 210 nm. The column temperature was 40 and the injection volume was 100 µl. Results The average recoveries were 99.68% for desogestrel and 99.40% for ethinylestrsdiol, and the stability of working solutions was acceptable in 12 h. The calibration curves were linear within the range of(0.06-0.36)µg/ml (r=0.9999)for desogestrel, (0.012-0.072)µg/ml (r=0.9999)for ethinylestradiol, respectively. Conclusion The method is convenient and precise in the dissolution determination of desogestrel and ethinylestradiol tablets.