RP-HPLC method development and validation of capecitabine in pharmaceutical dosage form

Abstract

A simple, accurate, rapid, and stability-indicating RP-HPLC method for a Capacetabine has been developed and subsequently validated in commercial tablets. The pr oposed HPLC method utilizes Shimadju ODS (C8) RP Column, 150 mm x 4.6 mm. and mobile phase consisting of a mixture of Buffer (0.01 M potassium dihydrogen phosphate & pH adjusted to 2.2 with ortho phosphoric acid) and Methanol in a ratio of 40:60 Quantitations was achieved with UV detection at 260 nm. The method was validated in terms of accuracy, precision, linearity, limits of detection, limits of quantitation, and robustness. This optimized method has been successively applied to pharmaceutical formulation and no interference from the tablet excipients was found.  Capecitabine drug products were subjected to acid, base, neutral hydrolysis, oxidation, dry heat, and photolytic stress conditions and the stressed samples were analyzed by the proposed method. As the proposed RP -HPLC method could effectively separate the drugs from i ts degradation products, it can be employed as stability -indicating method for the determination of instability of these drugs in bulk and pharmaceutical dosage form.