Development and validation of stability indicating HPLC assay method for determination of mesalamine in bulk drug and tablet formulation

Abstract

The objective of the current study was to develop simple, precise and accurate stability indicating by Gradient RP-HPLC assay method and validated for determination of Mesalamine in solid pharmaceutical dosage forms. Gradient RP-HPLC separation was achieved on an analytical C18 R column (250 mm × 4.6 mm i.d., 5 μm particle size) using mobile phase of Water: Methanol (80:20 v/v) at a UV detector. The drug was subjected to acid degradation, alkaline degradation, oxidation, photolysis and heat to apply stress condition. The method was validated for specificity, linearity, precision, accuracy, robustness and solution stability. The method was linear in the drug concentration range of 10-60 μg/ml with a correlation coefficient 0.999. The method was also found to be robust as indicated by the % RSD values which are less than 2%. The stress degradation studies showed that Mesalamine undergoes degradation in acid, base, oxidation, dry heat (2.1%, 1.86%, 1.60%, 1.33% respectively). Degradation products produced as a result of stress studies did not interfere with detection Mesalamine and the assay can thus be considered stability indicating.