Analytical Method Development and Validation of Ethinyl Estradiol and Drospirenone by Using RP-HPLC in Bulk and Pharmaceutical Dosage Form

This approach involves employing Reverse Phase-HPLC (High Performance Liquid Chromatography) to facilitate method development and validation, focusing on the stability and combined tablet formation of Estetrol & Drospirenone.The analysis was conducted using an Agilent Eclipse XDB column (250x4.6 mm, 5 ) with an Acetonitrile:HSA (70:30) solution, completing the run within 6.0 minutes.The Limit of Detection (LOD) and Limit of Quantification (LOQ) were determined to be 10mg/L, with a recovery rate ranging from 98% to 102%, indicating satisfactory recovery levels.Validation results confirmed adequacy, with acceptable outcomes for bulk and information analysis.The Relative Standard Deviation (RSD) values below 2.0% demonstrate the accuracy and precision of this approach.Furthermore, a retention formation assay revealed 100.24% presence of the formation.This validated method meets the criteria for global regulatory filing, ensuring specificity, precision, linearity, and accuracy.Linearity analysis conducted at stages ranging from 10% to 150% yielded a regression coefficient of 0.999.