ABSTRACT

The main aim of this research work is to estimate and validate the capecitabine in the bulk and formulation. Method development was carried out by Lab India-T60, UV/VIS double beam spectrophotometer and matched quartz cells were used for the development of capecitabine. The maximum absorbance of capecitabine was found at 308nm with photo diode array detector. Validation was done according to ICH Q2(R1) guidelines. Linearity for capecitabine was 5-30?g/mL with the correlation coefficient [R2] 0.999. Accuracy was performed at three concentration levels of 80%, 100% and 120% and the percentage recoveries were found to be within the ranges of 98-102%. Precision results were found to be within the limits of acceptance criteria and method was found to be robust with %RSD limit of NMT 2.0. The LOD and LOQ were found to be 1.0?g/mL and 3.41?g/mL respectively. The method was validated statistically and estimated the capecitabine successfully in the bulk formulations. Hence the proposed method can be applied to routine analysis. Keywords: Capecitabine, UV spectrophotometer, Validation
Publication date: 01/02/2023

https://ijbpas.com/pdf/2023/February/MS_IJBPAS_2023_6829.pdf

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https://doi.org/10.31032/IJBPAS/2023/12.2.6829