“VALIDATION OF STABILITY INDICATING HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR DETERMINATION OF ASSAY OF MESALAMINE DRUG IN THE PHARMACEUTICALS TABLET FORMULATIONS USING SODIUM BENZOATE AS AN INTERNAL STANDARD”
Shaikh Javed Shaikh Afzal*, Suresh C. Ameta and Pathan Mohd. Arif Ali Khan
ABSTRACT
Mesalamine is an anti-inflammatory drug used to treat inflammation of the digestive tract (Crohn's disease) and mild to moderate ulcerative colitis. Validation of stability indicating Simple, Specific, Precise, Accurate, Linear, Rugged, Robust High Performance Liquid Chromatographic method of analysis for determination of assay of Mesalamine drug in the pharmaceuticals tablet formulations using Sodium benzoate as an internal standard was performed. The assay was accomplished using a mixture of Methanol and Buffer solution in the volume ratio of 65:35 v/v as mobile phase on Hibar RP-18e, 250 mm x 4.6mm, 5μ as chromatographic column at a flow rate of 1.000 ml per min and a wavelength of 240 nm with a UV detector. The temperature of auto injector and column oven was 100C and 300C receptively. The Injection volume kept as 10 μL. Linearity of the analytical method was evaluated at concentration range of 5.0002 μg/ml to 339.9986 μg/ml with Correlation coefficient (r) value more than 0.999. The LOD and LOQ were 1.4558μg/mL and 4.4116μg/mL respectively. The retention time found to be 6.17 min for Mesalamine and 4.21 min for internal standard respectively. Specificity, Method Precision, System Precision, Ruggedness, Robustness, Recovery, Stability of analytical solution, Filter paper selection study, Stress testing (Force Degradation) at various conditions were performed as per the ICH (Q2) recommendations. All the results were found with in acceptance criteria.
Keywords: Mesalamine, Sodium benzoate, High Performance Liquid Chromatographic, Force degradation studies, Assay.
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