Pawar Geetanjali Raosaheb
Research Scholar, Monad University, Hapur
Sourobhi Datta
Professor, Monad University, Hapur
Abstract
Capecitabine, a prodrug of 5-fluorouracil, is widely used in the treatment of various cancers, including colorectal, breast, and gastric cancers. Ensuring the stability and accurate quantification of capecitabine is crucial for its efficacy and safety in clinical practice. In this study, a stability indicating Ultra Performance Liquid Chromatography (UPLC) method was developed and validated for the quantitative determination of capecitabine in pharmaceutical formulations. The UPLC method utilized a reverse-phase C18 column with a mobile phase consisting of acetonitrile and 0.1% formic acid in water, delivered in an isocratic mode at a flow rate of 0.4 mL/min. Detection was performed at a wavelength of 220 nm. The stability indicating capability of the method was demonstrated through forced degradation studies under various stress conditions, including acidic, basic, oxidative, thermal, and photolytic stress. Capecitabine remained stable under all stress conditions, with no significant degradation observed. Additionally, the method showed good selectivity, specificity, precision, accuracy, and robustness in the quantification of capecitabine. Overall, the developed UPLC method provides a reliable and sensitive approach for the quantitative determination of capecitabine in pharmaceutical formulations. Its stability indicating nature ensures the accurate assessment of capecitabine stability and potency, thereby facilitating quality control and assurance in the production and use of capecitabine-based medications.
Keywords: Clinical, Pharmaceutical, Acetonitrile, Formic Acid, Quantification.