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Method Development and Validation for Desogestrel and Ethinylestradiol in Combined Pharmaceutical Dosage Form by RP-HPLC

Sanjay Bais, Anil Chandewar, Imran Popte, Indrajeet Singhvi and Khemchand Gupta

A simple, rapid, sensitive RP-HPLC method for the simultaneous determination of Desogestrel and Ethinyloestradiol in pharmaceutical dosage forms was developed the analyte were resolved using KH₂ PO₄ Buffer (0.02M): Acetonitrile (50:50), at a flow rate of 2.0ml/min, on HPLC auto sampler system containing UV- visible and fluorescence detector with Empower software and Zorbax SB Phenyl C18 column (4.6×150 mm). Detector Fluorescence detector for Ethinylestradiol UV detector for Desogestrel, For the estimation the detection wavelength was taken as 310 nm Emission and 285 nm excitation Ethinyloestradiol and 210 nm for Desogestrel. Linearity for detector response was observed in the concentration range of 10-150% of test concentration. Correlation coefficient (r) for calibration curve was found to be 1.0. Retention times were found to be 2.4 min and 13.9 min for Ethinyloestradiol and Desogestrel respectively. Percent recovery was found to be within the range of 98.0% to 102.0%. The percent RSD for the analyzed tablet and recovery studied was less than 2. The results of recovery studies were found to be linear in the range 50% to 150% of test concentration. Results of the analysis were validated statistically and by recovery studies. The developed method was found to be precise, selective and rapid for the simultaneous determination of Desogestrel and Ethinyloestradiol in bulk and in pharmaceutical dosage form.