The aim of the study was to develop and validate a visible spectrophotometric method for the quantitative estimation of mesalamine in pure form and in formulations i.e. in tablets and suppositories. 0.1N HCl selected as solvent, 0.5 ml of 0.5% MBTH used as chromogenic reagent and 2 ml of 1% cerric ammonium sulphate solution was added as oxidizing agent to develop the color. The intensity of the developed brown colored complex measured at an absorption maximum of 476 nm. Beer-Lambert’s law was obeyed within the concentration range of 0.5 - 6.0 μg/ml and the correlation coefficient was found to be 0.999. LOD and LOQ were 0.05 and 0.17 μg/ml respectively. The developed method validated for accuracy and precision as per ICH Q2R1 guidelines. The method successfully applied for the quantitative estimation of the drug in tablets and suppositories and the percentage recoveries were found to be 99.0% and 98.4% respectively. This method can be used for routine analysis of mesalamine pure drug and its formulations.
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