A Sensitive and Economical Different Spectroscopic Methods Development and Validation for the Quantification of Capecitabine and Stress Degradation Studies

Abstract

Objective: The present investigation aims to develop an efficient, rapid, sensitive, selective, linear, and accurate method for analyzing capecitabine in bulk and tablet dosage form by UV-spectroscopy approaches. Methods: Capecitabine is an estimation by three different developed methods with different UV detection, method A (zero-order spectrophotometric method) at 239 nm, method B (first-order spectrophotometric method) at 231 nm, and method C (area under the curve spectrophotometric method) at 230 to 248 nm. The method's validation and stress degradation studies were done following the International Conference on Harmonization (ICH) guidelines. Results: The methods were validated using the prescribed parameters like system suitability, LOD, LOQ, accuracy, precision, robustness, specificity, etc. The relative standard deviation (% RSD) of the peak area observed in each case was found within the accepted range (<2%). The linearity study's coefficient of correlation (R2) value was<0.99. The methods were quantified accurately in the presence of degraded products. Conclusion: The developed simple and economical method is a suitable option for the qualitative and quantitative study of capecitabine in bulk and tablets, even in its degraded products, which may arise because of oxidation, hydrolysis, thermal, and photolytic decomposition.