Development and Validation of a UV-Spectrophotometric Method for Simultaneous Quantification of Ofloxacin and Ornidazole in Pharmaceutical Formulations

Research Article

Abstract

A simple, rapid, and cost-effective UV-spectrophotometric method was developed and validated for simultaneous determination of Ofloxacin and Ornidazole in combined tablet formulations. The method utilized maximum absorption wavelengths of 294 nm for Ofloxacin and 319 nm for Ornidazole in a solvent system consisting of 0.1N acetic acid and water (10:90 v/v). The developed method had excellent linearity in the concentration range of 10-50 µg/mL for both drugs, with correlation coefficients of 0.9998 and 0.9999 for Ofloxacin and Ornidazole, respectively. Method validation following ICH guidelines confirmed high precision with relative standard deviation values below 2% for both intra-day and inter-day analyses. Recovery studies yielded excellent results ranging from 98.52% to 100.04%, indicating high accuracy. The limits of detection were determined to be 0.360 µg/mL for Ofloxacin and 0.488 µg/mL for Ornidazole, while the limits of quantification were 1.092 µg/mL and 1.481 µg/mL, respectively. The developed method showed robust performance across different analysts and experimental conditions. The validated method was successfully applied to commercial tablet formulations, providing accurate and reliable results. This method offers advantages of simplicity, accuracy, and cost-effectiveness for routine quality control of Ofloxacin and Ornidazole in pharmaceutical preparations