Journal of Chemical and Pharmaceutical Research (ISSN : 0975-7384)

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Original Articles: 2014 Vol: 6 Issue: 9

Stability indicating RP-HPLC method for the simultaneous determination of Ofloxacin and Flavoxate in bulk and pharmaceutical formulations

Abstract

A simple and precise stability indicating RP-HPLC method was developed and validated for the simultaneous determination of ofloxacin and flavoxate in pharmaceutical dosage forms. Chromatography was carried out on Inertsil ODS C18 (250mm x 4.6mm 5 μ particle size) using a mobile phase of Phosphate buffer (KH2PO4): acetonitrile (52:48 % v/v) adjusted to pH 4.0 with 0.1% orthophosphoric acid at a flow rate of 1.0 ml/min. The analyte was monitored using PDA detector at 225 nm. The retention time was found to be 2.197 min and 3.514 min for Ofloxacin and Flavoxate respectively.Linearity was observed in the concentration range of 10-60 μg/ml for both Ofloxacin and Flavoxate with correlation coefficient of 0.999. The mean recoveries obtained for Ofloxacin and Flavoxate were found to be 99.96% and 99.93% respectively. Stress testing which covered acid, alkali hydrolysis, peroxide, photolytic and thermal degradation was performed to prove the specificity of the proposed method and degradation was achieved. The developed method has been statistically validated according to ICH guide lines and found to be simple, precise and accurate with the prescribed values. Thus the proposed method was successfully applied for the stability indicating simultaneous estimation of Ofloxacin and Flavoxate in routine quality control analysis in bulk and pharmaceutical formulations.