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Method Development and Validation for Quantitative Analysis of Rupatadine Fumarate by Ultraviolet Spectrophotometry

M. Shaiba, M. Sindhura, K. Raghavi and R. Prashanthi

A simple and sensitive UV spectrophotometric method for the determination of rupatadine fumarate in tablet dosage form has been developed. Beer’s law is obeyed in the concentration range of 2- 20 µg/mL of rupatadine fumarate. Spectroscopic determination was carried out at an absorption maximum of 263 nm for rupatadine fumarate using methanol as a solvent. In UV spectroscopic method, the linearity over concentration range of rupatadine fumarate was 2-20 µg/mL with correlation coefficient 0.999. The mean assay and recovery percentage was found to be 99.4% and 99.25%, respectively. The results of the analysis for the method have been validated statistically and by recovery studies. The results obtained with the proposed methods are in given limits. This method is extended for analysis of drug in pharmaceutical formulation.