HPLC Assay Method Development and Validation for Quantification of Capecitabine in Tablets and Forced Degradation Samples

Abstract

A simple, rapid accurate and forced degradation indicating RP-HPLC method was developed for the determination of Capecitabine in pure and tablet dosage form. The mobile phase used contains 0.1% Acetic acid, Methanol and Acetonitrile in the ratio of 35:60:5 v/v. The linearity range is found over the concentration range of 50-150µg/ml. The Inertsil ODS, C18, 3V, 250 x 4.6 mm, 5µm with UV detection 250 nm is used. The RT is found to be 6.4 mins. The method was statistically validated for accuracy, linearity, precision, robustness, specificity and range. Quantitative and recovery studies of the dosage form were also carried out and analyzed; the % RSD from recovery studies was found to be within limits. The specificity of the method was ascertained by forced degradation studies by acid, alkali hydrolysis and oxidation and about 35% of drug is degraded in acidic medium. Due to simplicity, rapidity and accuracy of the method, the method will be useful for routine analysis and checking purity of Capecitabine tablet. The method further can be investigated for pharmacokinetic and biopharmaceutical analysis.