Development and Validation of RP-HPLC Method for the Estimation of Gemifloxacin Mesylate in Bulk and Pharmaceutical Dosage Forms

A reverse phase high performance liquid chromatography (RP-HPLC) has been developed for the estimation of Gemifloxacin mesylate in bulk drug and pharmaceutical dosage form. The quantification was carried out using C18 column (250mm × 4.6mm i.d, 5 mm) in an isocratic mode with a mobile phase consisting of methanol: 7% formic acid (80:20v/v), pH was adjusted to 2.1, at a flow rate of 1 ml/min. The separation was performed at ambient temperature and detection was carried out at 260nm. The retention time of the drug was found to be 2.36min and method produced linear response in the concentration range of 10-60 μg/ml (R˜0.9991). As per ICH guidelines, the method was validated for linearity, precision, accuracy, LOD, LOQ and robustness for bulk drug and pharmaceutical dosage form.