A Validated LC Method for the Simultaneous Determination of Drospirenone and Ethinylestradiol in Tablet Dosage form by Using Combine Fluorescence and UV Detectors

Abstract

A simple, precise and accurate reversed-phase liquid chromatographic method has been developed for the simultaneous estimation of Drospirenone and Ethinylestradiol in tablet formulation. The chromatographic separation was achieved on a XTerra Phenyl 150 x 4.6 mm 5μ analytical column. A mixture of water and acetonitrile in the ratio of 35:65 v/v was used as the mobile phase. The flow rate of the mobile phase was 1.0 ml/min. UV detector wavelength 260 nm was used for the quantification of Drospirenone and FLD 285 nm Excitation, 310 nm Emission for Ethinylestradiol. The limit of detection and quantification for Drospirenone was 0.02 and 0.05ug/mL and for Ethinylestradiol 0.21 and 0.45 ng/mL respectively. The developed method was validated as per ICH guidelines with respect to specificity, linearity, limit of detection, limit of quantification, accuracy, precision and robustness. A method was found suitable for quality control analysis of Drospirenone and Ethinyl estradiol in tablet dosage form.