Development and Validation of Stability Indicating RP-HPLC Method for Amoxicillin and Clavulanate Potassium Related Impurities in Pharmaceutical Dosage Forms

A B S T R A C T A simple, cost effective, stability indicating reversed-phase High Performance Liquid Chromatography method was developed for separation and quantification of seventeen specified known related impurities in Amoxicillin and Clavulanate Potassium pharmaceutical dosage form using simple gradient method. The chromatographic conditions comprised areversedphase Agilent eclipsed C18 column and UV detection at 210 nm with 1.0 mL / min flow rate at 45 ºC column oven temperature. In gradient mobile phase composition-A contains 0.05 M potassium dihydrogen phosphate buffer of pH 3.4 and Composition-B contains mixture of Acetonitrile and 0.05 M potassium dihydrogen phosphate of pH 4.2 in 80:20. The method validation data showed excellent results for Precision, Linearity, Specificity, Accuracy, Limit of detection, Limit of Quantification and robustness.