Abstract

A simple, accurate and precise stability indicating method for simultaneous estimation of ofloxacin and racecadotril in bulk and marketed formulation was developed and validated by RP-HPLC. The chromatographic separation of this method was carried out by Waters X Bridge Stainless steel C18 column (250 mm × 4.6 mm, 5 μm) packed with ODS using methanol: acetonitrile and water (40:40:20 V/V/V) as mobile phase. The pH of the mobile phase was 2.7, adjusted by orthophosphoric acid. The flow rate of the instrument was set at 0.8 mL min-1 and wavelength of UV visible detector was set at 210 nm at room temperature. The method showed good linearity and the correlation coefficients of ofloxacin and racecadotril were found to be 0.9966 and 0.9991, respectively. The mean recovery values were calculated to be 99.1 and 100.03, respectively. This method could be applied successfully for the estimation of both the drugs in bulk and pharmaceutical formulation. The stress studies for this method were performed to confirm that the specificity and stability was achieved.

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