Development and Validation of a Dissolution Test with Spectrophotometric Analysis for Gemifloxacin in Tablet Dosage Form

The aim of this work was to develop and validate a dissolution test for Gemifloxacin mesylate tablets using spectrophotometric method. The dissolution established conditions were: 900 mL of 0.01N HCl pH 2.0 as dissolution medium, using a paddle apparatus at a stirring rate of 50 rpm. The drug release was evaluated by UV spectrophotometric method at 271 nm. The method was validated to meet requirements for a global regulatory filing which includes linearity, specificity, precision, accuracy and ruggedness. In addition, filter suitability and drug stability in medium were demonstrated. The comparison of the obtained dissolution profiles of tablets, obtained from three different batches (A, B and C) of 320 mg Gemifloxacin mesylate was performed and the results showed no significant difference among the products.