METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF DROSPIRENONE AND ETHINYLESTRADIOL IN BULK AND PHARMACEUTICAL DOSAGE FORMS BY RP-HPLC

The primary aim of this study is to develop and validate a novel Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method for the simultaneous estimation of Drospirenone and Ethinylestradiol in bulk and pharmaceutical dosage forms. This involves a comprehensive analysis of their physical and chemical properties to optimize chromatographic conditions for accurate, precise, and reproducible quantification. The method development includes selecting an appropriate mobile phase, stationary phase, flow rate, column temperature, and detection wavelength to achieve optimal separation and peak resolution. Further, the method will be validated as per ICH guidelines, assessing parameters such as linearity, accuracy, precision, specificity, detection limits, and robustness to ensure reliability for routine pharmaceutical analysis. The ultimate goal is to establish an efficient and reproducible RP-HPLC technique for quality control and formulation analysis of Drospirenone and Ethinylestradiol.