Spectrophotometric methods for the determination of mesalamine in bulk and pharmaceutical dosage forms

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 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.

[1]  Wuk-hee Hong Determination of mesalazine by RP-HPLC , 2008 .

[2]  M. Fonseca,et al.  Validation of HPLC, DPPH and nitrosation methods for mesalamine determination in pharmaceutical dosage forms , 2007 .

[3]  M. Nobilis,et al.  High-performance liquid-chromatographic determination of 5-aminosalicylic acid and its metabolites in blood plasma. , 2006, Journal of chromatography. A.

[4]  Vladimir Grdinić,et al.  Prevalidation in pharmaceutical analysis. Part I. Fundamentals and critical discussion. , 2004, Journal of pharmaceutical and biomedical analysis.

[5]  K. Zhu,et al.  Synthesis, characterization and in vitro release of 5-aminosalicylic acid and 5-acetyl aminosalicylic acid of polyanhydride--P(CBFAS). , 2003, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.

[6]  Biljana Nigović,et al.  Determination of 5-aminosalicylic acid in pharmaceutical formulation by differential pulse voltammetry. , 2003, Journal of pharmaceutical and biomedical analysis.

[7]  R. Gotti,et al.  Determination of 5-aminosalicylic acid related impurities by micellar electrokinetic chromatography with an ion-pair reagent. , 2001, Journal of chromatography. A.

[8]  J Ermer,et al.  Validation in pharmaceutical analysis. Part I: an integrated approach. , 2001, Journal of pharmaceutical and biomedical analysis.

[9]  J. Brandys,et al.  Validation of a LC method for the determination of 5-aminosalicylic acid and its metabolite in plasma and urine. , 2000, Journal of pharmaceutical and biomedical analysis.

[10]  G. Carlucci,et al.  Simultaneous determination of 5-aminosalicylic acid, acetyl-5-aminosalicylic acid and 2,5-dihydroxybenzoic acid in endoscopic intestinal biopsy samples in humans by high-performance liquid chromatography with electrochemical detection. , 1995, Journal of pharmaceutical and biomedical analysis.

[11]  M. B. Devani,et al.  Spectrophotometric determination of amino acids and their dosage forms. , 1993 .

[12]  P. Miner,et al.  New therapeutic agents in the treatment of inflammatory bowel disease. , 1992, The American journal of medicine.