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Description

A stability indicating RP-HPLC method was developed and validated for the determination of Gemifloxacin in tablet formulation. The drug was subjected to forced degradation study in terms of acidic, thermal, oxidative, photo and basic stresses. Degradation products produced as a result of stress testing were successfully separated through C18 column (250 x 4.6 mm, 5 μm) using ammonium acetate buffer (pH 2.7; 0.05 M) and acetonitrile (70:30, v/v) as a mobile phase at a flow rate of 0.7 mL/min. The diode array detection was performed at 272 nm. The method was linear over the concentration range of 0.256-128 µg/mL with correlation coefficient equal to 0.9990. The LOD and LOQ were 10 ng/mL and 30 ng/mL respectively. The proposed method was validated according to ICH guidelines. The method showed adequate separation of Gemifloxacin from its stress induced degradation products and excipients with resolution greater than 1.5 within 11 minutes. The method is therefore considered as stability indicating, rapid and suitable for the chromatographic purity and assay determination of Gemifloxacin not only in routine quality control analysis but also for stability studies.