DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR DETERMINATION OF GEMIFLOXACIN MESYLATE IN BULK AND TABLET DOSAGE FORM

Md. Saiful Islam*, Md. Taleb Hossain, Md. Zakir Hossain akon, Abdul Kader, Sukalyan Kumar Kundu and Md. Rafiquzzaman.

ABSTRACT

A simple, rapid reversed phase high performance liquid chromatographic method was developed and validated for estimation of Gemifloxacin Mesylate in bulk and pharmaceutical dosage form. Optimum separation was achieved at 8.58±0.03 min using an end-capped C18 column (250 mm × 4.6 mm i.d, 5μ particle size) by isocratic elution with a mixture of citric acid-sodium citrate buffer (pH 2.8): acetonitrile in the ratio of 70:30:(v/v) as mobile phase. Column effluents were monitored at 267nm at a flow rate of 1mL/min.The method was validated for linearity, accuracy, precision and specificity as per ICH guidelines. The developed and validated method was successfully used for the quantitative analysis of commercially available dosage form. The calibration curve was linear over the concentration range of 0.096-0.144 mg.mL-1 for Gemifloxacin Mesylate. The LOD and LOQ values were found as 0.628 μg.mL-1 and 1.90 μg.mL-1 respectively. The high percentage of recovery confirms the suitability of the method for the estimation of Gemifloxacin Mesylate in pharmaceutical dosage form.

Keywords: Gemifloxacin Mesylate (GFM) tablets, Potency, RP-HPLC, Method validation.