Development and Validation of HPLC Assay Method for Determination of Mesalamine in Bulk Drug and Tablet Formulation

K. Sivarami Reddy; B. Ramachandra; N. V. S. Naidu

Abstract: The objective of the current study was to develop simple, precise and accurate RP-HPLC assay method was developed and validated for rapid assay of Mesalamine in bulk and tablet dosage form. Isocratic elution at a flow rate of1.0 mL/min was employed on Waters (alliance) HPLC C18, 100X4.6, 5?.column using mobile phase of mixed buffer and Acetonitrile (65: 35 v/v) at UV detector. The UV detection wavelength was 258 nm and 20 ?L of sample was injected, retention time for Mesalamine was 3.214 min. The method was linear in the drug concentration range of 10-60 ?g/ml with a correlation coefficient 0.998. The method was validated for specificity, linearity, precision, accuracy, robustness and solution stability and also found to be robust as indicated by the % RSD values which are less than 2%. The method was validated as per the ICH guidelines, successfully applied for routine analysis of Mesalamine in bulk samples and its formulations.

Keywords: Mesalamine, assay validation, RP-HPLC Method