DEVELOPMENT AND VALIDATION OF BROMATOMETRIC, DIAZOTIZATION AND VIS-SPECTROPHOTOMETRIC METHODS FOR THE DETERMINATION OF MESALAZINE IN PHARMACEUTICAL FORMULATION.

Three new methods were developed for the quantitative determination of mesalazine in the form of the pure substance or in the form of suppositories and tablets - accordingly: bromatometric, diazotization and visible light spectrophotometry method. Optimizing the time and the temperature of the bromination reaction (50⁰C, 50 min) 4-amino-2,3,5,6-tetrabromophenol was obtained. The results obtained were reproducible, accurate and precise. Developed methods were compared to the pharmacopoeial approach - alkalimetry in an aqueous medium. The validation parameters of all methods were comparable. Developed methods for quantification of mesalazine are a viable alternative to other more expensive approaches.