Author(s): Asheesh Singh, Bhawna Mishra, Naveen Sharma, Khushboo Mishra4
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 Prontosil C18ace-EPS, 30cmX3.0 mm; followed in series by chromalith RP-18E C18, 10cm x 4.6 mm, 3µm and flow rate of 0.5 ml/min and injection ?olu?e ?? μL. The detection was carried out at 222 nm for drospirenone and for Ethinyl estradiol Fluorescence Detector: Excitation at 215nm and Emission at 315nm Fluorescence Detector: Excitation at 215nm and Emission at 344nm. Retention Time of Ethinyl estradiol and drospirenone were found to be 47 minutes and 34 minutes and For Ethinyl Estradiol Related compound B 41 minutes. 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.