Method Development and Validation for Simultaneous Estimation of Ethinyl Estradiol and Drospirenone and Forced Degradation Behavior by HPLC in Combined Dosage Form

Abstract

A simple, accurate, rapid and precise isocratic High performance liquid chromatographic (HPLC) method was developed and validated for the determination of ethinyl estradiol and drospirenone in tablet formulation. The method employs Waters HPLC system on Thermo Hypersil BDS C18 Column (4.6×250 mm and 5 µm) and flow rate of 1.0 ml/min with a load of 15 µl. Acetonitrile and ammonium acetate buffer was used as mobile phase in the composition of 30:70. The detection was carried out at 258 nm. Linearity ranges for ethinyl estradiol and drospirenone were 0.06-0.18 µg/ml, 6-18 µg/ml respectively. Retention Time of ethinyl estradiol and drospirenone were found to be 1.4 min, 5.3 min respectively. Percent Recovery study values of ethinyl estradiol and drospirenone were found to be within 97-103%. The combination product is exposed to acid/base, hydrolytic, photolytic and peroxide stress conditions and the stressed samples were analyzed. This developed method was successfully utilized for the quantitative estimation of ethinyl estradiol and drospirenone in pharmaceutical dosage forms. This method was validated for accuracy, precision, linearity and Robustness as per ICH guidelines.