Validated stability-indicating HPLC method for analysis of gemifloxacin in tablet formulations

Abstract

Summary A stability-indicating reversed-phase high-performance liquid chromatographic method has been developed for analysis of gemifloxacin in tablet formulations. When the drug was subjected to forced degradation under acidic, basic, thermal, oxidative, and photolytic conditions, the degradation products produced were successfully separated on a 250 mm × 4.6 mm, 5-μm particle, C18 column with ammonium acetate buffer (pH 2.7; 0.05 m)-acetonitrile 70:30 (υ/υ) as mobile phase at a flow rate of 0.7 mL min−1. Diode-array detection was performed at 272 nm. The method was validated in accordance with ICH guidelines. Response was a linear function of concentration over the range 0.256–128 μg mL−1 (correlation coefficient 0.9990). The limits of detection and quantification were 10 and 30 ng mL−1, respectively. Separation of gemifloxacin from its stress-induced degradation products and excipients was adequate; resolution was >1.5 within 11 min. The purity index for the gemifloxacin peak after all types of stress was >0.999, indicating complete separation of the analyte peak from the degradation products. The method can therefore be regarded as stability-indicating. It is rapid, and suitable for purity and assay determination not only for routine quality control but also in stability studies.