Development and validation of RP-HPLC method for the simultaneous estimation of Ofloxacin and Flavoxate HCl in combined dosage form.

A simple, precise and sensitive reverse-phase high performance liquid chromatographic method was developed and validated for the simultaneous estimation of Ofloxacin and Flavoxate Hcl in pharmaceutical formulations. Chromatographic separation was performed on a High performance liquid chromatography equipped with auto sampler and UV detector. Good sensitivity for all analyte was observed with UV detection at wavelength of 301 nm, Separation was performed on a BDS Hypersil C18 (250 X 4.6mm) 5µm,using a mixture of 0.1% Triethyl Amine buffer pH 4 and Acetonitrile in the ratio of (40:60, v/v). The method results in excellent separation with good resolution between the two analytes. The within day variation between Ofloxacin and Flavoxate Hcl 1.72 and 1.97 % . The recovery was greater than 95 % with RSD less than 1.95 %. The method was validated according to ICH guidelines by performing linearity, accuracy, precision, limits of quantitation and selectivity. The results show the method is suitable for its intended use.