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

Introduction Stability of pharmaceutical product may be defined as, the capacity of a particular formulation 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 with UV–Visible detector method for the determination of mesalamine using phenomenex RP-C18 (250 × 4.6 mm, packed with Luna 5 μ) 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 μl. The separation was performed at ambient temperature. Eluents were monitored by UV detector set at 230 nm. Results The developed method was statistically validated for the linearity (20–50 μg/ml) and the results of precision (≤2%), accuracy, robustness, specificity, LOD (0.19 μg/ml) and LOQ (1.8 μg/ml) are well within the 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 the analyte peak with significant difference in their RT values.