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Abstract

A simple, specific, accurate, reliable, and precise reverse-phase highperformance liquid chromatographic method was developed by quality by design approach and validated for the estimation of Capecitabine in bulk and tablet dosage forms. A surface methodology was used to optimize the data with a three-level Box Behnken Design (BBD) was used. Mobile phase composition, flow rate, and column oven temperature were chosen as the three variables. The linearity was over the concentration range of 1-15 μg/ml with a correlation coefficient of 0.999. The LOD and LOQ were found to be 0.103 ug/mL and 0.313 ug/mL, respectively. Chromatographic separation was carried out by using a mobile phase of methanol: water (70:30 V/V) on Kromasil C18 column (250 mm X 4.6mm ID, 5 μm) in an isocratic mode at a flow rate of 0.9 ml/min with UV detection at 239 nm. The developed RP-HPLC method yielded a suitable retention time for Capecitabine of 4.70 min, which was optimized using the Design-Expert version 7.0.0. The percentage recovery was found to be 99.81%. The RSD percentage for methods precision was less than 2%. The developed methods were found to be precise and accurate for estimating Capecitabine in pharmaceutical dosage forms and could be used for routine analysis.