Stability Indicating RP-HPLC Method for the Determination of Gemifloxacin in Pharmaceuticals

A simple, rapid, accurate and precise stability indicating RP-HPLC method was developed for the determination of gemifloxacin in pure and tablet dosage forms. Separation of the drug was achieved on a reverse phase Symmetry C18 column. The method showed a linear response for concentration in the range of 10–50 μg/ml using acetate buffer: methanol as the mobile phase in the ratio of 38:62 v/v with detection at 273 nm with a flow rate of 1 ml/min and retention time was 2.044 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 of gemifloxacin in pharmaceutical formulation.