APPLICATION OF EMISSION INTENSITY IN QUANTIFICATION AND FORCED DEGRADATION STUDIES OF MESALAMINE

Abstract

A simple and sensitive spectrofluorimetric method has been developed for the estimation of mesalamine (MES). Linearity was obeyed in the range of 0.1-2.5 µg/mL in distilled water as solvent at an emission wavelength (λem) of 501 nm after excitation (λex) at 332 nm, with a good correlation coefficient of 0.999. The limit of detection and limit of quantification for this method were 0.05 and 0.1 µg/mL, respectively. The developed method was statistically validated as per ICH guidelines. The percentage relative standard deviation values were found to be less than 2 for accuracy and precision studies. The assay results obtained were in good agreement with the labeled amounts of the marketed formulations. This validated method was extended to study the degradation behavior of mesalamine in various conditions such as acid, alkaline, oxidative, thermal, and UV effects. Although there was no degradation observed in oxidative, thermal, UV effect, 41.9 % and 11.6 % amount was degraded in acid and alkaline media, respectively. The proposed method was effectively applied to routine quality control analysis of mesalamine in bulk and marketed formulations.