Validation of stability indicating RP-HPLC method for the estimation of mesalamine in bulk and tablet dosage form

摘要

Introduction: Stability of pharmaceutical product may be defined as, the capacity of a particularformulation in a specific container or closure system, to remain within its physical, chemical, microbiological,therapeutic and toxicological specifications.Method: The present paper deals with the development of a stability indicating reverse phase HPLC withUVeVisible detector method for the determination of mesalamine using phenomenex RP-C18(250 4.6 mm, packed with Luna 5 m) column. A mobile phase consisting of methanol: water (50:50)was employed in this study. The flow rate was kept at 0.9 ml/min and the injection volume was 20 ml. Theseparation was performed at ambient temperature. Eluents were monitored by UV detector set at230 nm.Results: The developed method was statistically validated for the linearity (20e50 mg/ml) and the resultsof precision ( 2%), accuracy, robustness, specificity, LOD (0.19 mg/ml) and LOQ (1.8 mg/ml) are well withinthe limits. Over all % Recovery was found to be 99.72%.Conclusion: The specificity of the method was ascertained by force degradation studies by acid hydrolysis,alkali hydrolysis and degradation by oxidation. The degraded products were well resolved from theanalyte peak with significant difference in their RT values.