Development and validation of spectrofluorimetric method for the quantification of Capecitabine in bulk and tablets

INTRODUCTION: A new, simple and affordable spectrofluorimetric method was established for the quantification of capecitabine in bulk and in marketed formulation.
METHODS: Native fluorescence of capecitabine in 0.1% w/v cetrimide was measured at 386 nm after excitation at 313 nm.
RESULTS: Linear relationship between fluorescence intensity and the capecitabine concentration was noticed in 0.2-1.0 µg/mL range. The method was supported by checking several validation parameters as stated by ICH guidelines. The limit of detection and quantification values (0.032 and 0.096 µg/mL, respectively) and results of validation parameters demonstrated that the method procedure was sensitive, accurate, precise and reproducible (% relative standard deviation < 2.0). The % assay in commercial formulation was found to be 99.2, which is in agreement with ICH guidelines.
DISCUSSION AND CONCLUSION: As a consequence of the above findings, developed method can be successfully adopted in routine analysis of capecitabine in pharmaceutical dosage forms.