DEVELOPMENT AND VALIDATION OF A STABILITY INDICATING ASSAY METHOD OF MESALAMINE BY USING DIFFERENT STRESS DEGRADATION CONDITIONSAbstract
A simple, sensitive, highly accurate UV spectrophotometric method has been developed for the determination of mesalamine in bulk and tablet dosage form. Solution of mesalamine in distilled water shows maximum absorbance at 330 nm. Beer’s law was obeyed in the concentration range of 2-16 μg/ml with the slope, intercept, correlation coefficient, detection and quantitation limits were also calculated. The proposed method has been applied successfully for the analysis of the drug in pure and in its tablets dosage forms. Result of percentage recovery and placebo interference shows that the method was not affected by the presence of common excipients. The method was validated by determining its sensitivity, accuracy and precision which proves suitability of the developed method for the routine estimation of mesalamine in bulk and solid dosage form. The method was then validated for different parameters as per the ICH (International Conference for Harmonization) guidelines. Mesalamine was subjected to stress degradation under different conditions recommended by ICH. The samples generated were used for degradation studies using the developed method.
S. H. Gatkal*, P. R. Mhatre, V. V. Chopade and P. D. Chaudhari
Department Of Quality Assurance Techniques, Modern College of Pharmacy Nigdi, Pune-411044 Maharashtra, India
20 September, 2012
06 November, 2012
22 December, 2012
01 January, 2013