Development and Validation of a Spectrofluorimetric Method for the Quantification of Capecitabine in Bulk and Tablets.

Abstract

Objectives: A new, simple, and affordable spectrofluorimetric method was established for quantification of capecitabine in bulk and in marketed formulations.

Materials and methods: Native fluorescence of capecitabine in 0.1% (w/v) cetrimide was measured at 386 nm after excitation at 313 nm.

Results: A linear relationship between fluorescence intensity and capecitabine concentration was noticed in 0.2-1.0 μg/mL range. The method was supported by checking several validation parameters as stated using International Conference on Harmonization (ICH) guidelines. The limit of detection (LOD) and quantification (LOQ) values (0.032 and 0.096 μg/mL, respectively) and results of validation parameters demonstrated that the method procedure were sensitive, accurate, precise, and reproducible (% relative standard deviation <2.0). The percentage assay in commercial formulation was found to be 99.2, which agrees with ICH guidelines.

Conclusion: Due to the above findings, developed method can be successfully adopted for routine analysis of capecitabine in pharmaceutical dosage forms.