Validation of RP-HPLC Method for Simultaneous Estimation of Cefixime Trihydrate and Clavulanate Potassium in Tablets

Abstract

A simple, accurate, precise, rapid and economic HPLC method has been developed and validated for the simultaneous estimation of cefixime trihydrate and clavulanate potassium in tablet dosage forms. The chromatographic separation was achieved on a Hypersil C18 column (4.6 x 250 mm, 5 μm particle size). For HPLC method development, a mobile phase consisting of methanol: 30 mM potassium dihydrogen phosphate buffer pH 3.0 adjusted with orthophosphoric acid (30:70 v/v) was used at flow rate of 1.0 ml/min. The optimum wavelength selected was 278 nm. Under these chromatographic conditions, cefixime trihydrate and clavulanate potassium peaks were well resolved, with retention times of cefixime trihydrate and clavulanate potassium being 5.8266 and 3.2633 min, respectively. The proposed method was found to have excellent linearity in the concentration range 20-100 μg/ml with correlation coefficients r2 = 0.9946 and 0.9926, respectively. The method was validated for linearity, precision, LOD, LOQ and robustness. The proposed method was optimized and validated as per the ICH guidelines.