Untitled

Abstract

It belongs to the group of medications called as anti-metabolites and is a fluoropyrimidine carbonate with anti-cancer properties. The chemotherapy drug capecitabine is taken orally and is used to treat metastatic colorectal and breast cancers. A review of the literature reveals several analytical techniques have been developed for Capecitabinein single and combined with other drugs. No QbD-assisted RP-HPLC method is available to estimate Capecitabine. So, present work describes the development and validation of QbD driven RP-HPLC method for Capecitabine. This method has been developed using Agilent 1100 series HPLC with ODS (water) column (150 × 4.5mm, 5 µm). Based on the RP-HPLC method development Mobile phase and Flow rate were selected as CAA and retention time, peak area, theoretical plates, tailing factor of drug were monitored using Design Expert 13.0.0.5. By applying CCD, 8 trials having 2 factors and 4 responses method had been selected for method development of capecitabine. The optimum method development was selected based on the criteria of Retention time, Peak area, Theoretical plates, Tailing factor. The retention time of Capecitabine is 2.721 min. The method was validated for specificity, linearity, accuracy, precision, limit of quantification, limit of detection, robustness in accordance with ICH guidelines. Limit of detection and limit of quantification for estimation of Capecitabine found to be 0.2371 µg/mL and 0.7185 µg/mL. INTRODUCTION:Capecitabine CAP [N4pentoxycarbonyl-5-deoxy-5-fluorocytidine] is an anticancer prodrug of 5-fluorouracil (5-FU) that was designed to undergo preferential conversion to 5-FU within tumors 1 . 5-FU has also been widely used as an anticancer agent in the chemotherapy of solid tumors but its efficacy is limited by dihydropyrimidine dehydrogenase catalyzed formation of dihydro-5-fluorouracil 2 .