Abstract

DEVELOPMENT AND VALIDATION OF UV SPECTROSCOPIC METHOD FOR DETERMINATION OF CAPECITABINE IN API AND FORMULATION

*E. Ramakrishna Goud, R. Nageswara Rao, S. Sulakshana, V. Ravisankar, L. Siva Sankar Reddy

Abstract

An effort has been made to develop a simple, accurate method to estimate capecitabine in API and pharmaceutical preparation and to validate the method, according to ICH guidelines. The absorbance maxima was recorded at a wavelength of 303 nm for phosphate buffer pH 7.4 which is shown in Beers law range was confirmed by linear curve of capecitabine, shown Linearity for capecitabine at concentration range of 10-30μg/ml. From the above studies the optical characteristics such as linearity range (10-30μg/ml), for phosphate buffer pH 7.4 of correlation coefficient (0.999), slope (0.0266) and intercept (0.0025) were calculated and results were found to be satisfactory. Quantitative data subjected to statistical analysis. The % RSD values < 2 indicate the precision of methodology. The accuracy was confirmed by recovery studies by adding a known amount of pure drug to the previously analyzed formulation and the mixture was analyzed by the proposed method was found to be 98% - 102%. The values are given in recovery was confirmed and shown.

Keywords: UV-Spectrophotometry, Capecitabine, Validation.