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ABSTRACT
Five simple, precise and cost effective spectrophotometric methods have been developed for the estimation of mesalamine in bulk and its pharmaceutical formulations. Mesalamine shows λ^sub max^ at 232.0 nm in zero order derivative spectrum (Method A), 241.0 nm in first order derivative spectrum (Method B), 244.5 nm in second order derivative spectrum (Method C) and 240.5 nm in third order derivative spectrum (Method D). Method E is based on calculation of Area under Curve (AUC) for analysis of mesalamine in the wavelength range of 227.0 - 237.0 nm. The drug follows the Beer-Lambert's law in the concentration range of 2.0 - 25.0 µg/ml in all the methods. The methods were validated by following the analytical performance parameters suggested by the International Conference on Harmonization. All validation parameters were within the acceptable range. The developed methods were successfully applied to estimate the amount of mesalamine in bulk and pharmaceutical dosage forms.
Key words: Mesalamine, derivative spectroscopy, Area under curve, UV spectrometry
Introduction
Mesalamine also known as Mesalazine, chemically known as 5-aminosalicylic acid (5-ASA) (Fig.1) is used for its local effects in the treatment of inflammatory bowel disease, including ulcerative colitis and Crohn's disease 1- 2. Despite the fact that it has been used for over 50 years, the mechanism of action of this drug remains uncertain. 5-ASA has been shown to be a potent scavenger of reactive oxygen species that play a significant role in the pathogenesis of inflammatory bowel disease, inhibition of natural killer cell activity, inhibition of antibody synthesis, inhibition of cyclo-oxygenase and lipoxygenase pathways and impairment of neutrophil function3-4. It is very slightly soluble in water, practically insoluble in alcohol, dissolves in dilute solutions of alkali hydroxides and in dilute hydrochloric acid5.
Literature survey revealed that only few HPLC6-12, spectrophotometric13-14 and differential pulse voltammetric15 methods are developed for the determination of mesalamine in bulk and pharmaceutical formulations. The aim of the present work is to develop and validate new spectrophotometric methods for the estimation of mesalamine in bulk and pharmaceutical formulations.
Experimental
Chemicals and Reagents
Mesalamine working standard was kindly provided by Alembic Ltd., (Vadodara, India) and was used as received. A commercial tablet formulation was purchased from a local market. Hydrochloric acid (analytical grade) solution, 0.1N, was prepared in...