Development and Validation of Simple UV Spectroscopic Method for the Quantification of Capecitabine in Its Pure Form
DOI:
https://doi.org/10.22270/ajprd.v14i5.1867Abstract
The present research was aimed to study two solvent blends comprising Methanol: 1%Orthophosphoric acid (OPA) (77.5:22.5) and Methanol: pH 6.8 Buffer (1:1) for the quantification of model anticancer drug Capecitabine (CAP) in pure sample by validating simple UV spectroscopic method. A precise, accurate, robust simple UV method was developed under standard conditions and underwent rigorous statistical validation guided by the valuable ICHQ2R1 guidelines, affirming their effectiveness as a successful analytical tool for the quantification of CAP in pure sample.A linear relationship was found between 4 to 20 μg/mL for Solvent A and 5 to 28 μg/mL for Solvent B with correlation coefficient R2was 0.9999 and 0.9999 respectively. The precision study indicates the method was reproducible, accurate with % RSD values less than 2% and highly robust. The results conclude that the developed method can be used for routine analysis of bulk and formulations containing CAP.
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