DESIGN, DEVELOPMENT AND VALIDATION OF AMOXICILLIN AND CLOXACILLIN FORMULATION BY HPLC

Abstract

Background: A simple, rapid and accurate and stability indicating RP-HPLC method was developed for the determination of amoxicillin and cloxacillin in pure and tablet forms. The method was validated with respect to linearity, precision, accuracy, and selectivity. The mean values of slope, intercept and correlation coefficient were 0.9991(r2) respectively. The % COV values for repeatability and intermediate precision studies were < 2 indicates good precision of the method. The recovery of the drug ranged from 99.95-100.72% from a mixture of degradation products. The method was specific to drug and also selective to degradation products. The method showed a linear response for concentrations in the range of 300-1500 ?g/ml using 0.01 M potassium dihydrogen phosphate (pH 5.0) buffer: acetonitrile [15:85] as the mobile phase with detection at 225.0 nm and a flow rate of 5 ml/min and retention time 15-20 min. The method was statistically validated for accuracy, precision, linearity, ruggedness, robustness, forced degradation, solution stability and selectivity. Quantitative and recovery studies of the dosage form were also carried out and analyzed; the % RSD from recovery studies was found to be less than 1. Due to simplicity, rapidity and accuracy of the method, we believe that the method will be useful for routine quality control analysis.