Development and Validation of Gradient RP-HPLC for Estimation of Impurities in Eplerenone Tablet dosage form

Abstract

A simple reverse phase gradient HPLC method used for simultaneous identification of Eplerenone impurities in market tablet dosage form. Poroshell ECC18 (50mmx4.6mmx2.7µm)column, mobile phase(gradient)A&B(70:30)it’s contain potassium dihydrogen orthophosphate diluent, acetonitrile and methanol mixture diluent (90:10) to adjust the ph3.2±0.05with ortho phosphoric acid. Flow rate 1ml/min and injection volume 2µl chromatograms observed at 240nm. System suitability parameters are passed so system is suitable for analysis. Validation parameters specificity, linearity, lod, loq, precision, accuracy, robustness and also Acid and Diene impurities all are within the limit method should be validated its use full for stability studies and other pharmaceutical analysis.