Analytical Method Development and Validation for the Determination of Allopurinol and Alphalipoic Acid Using Reverse Phase HPLC Method in Bulk and Tablet Dosage Form

Abstract

A new simple, accurate, precise and reproducible RP-HPLC method has been developed for the simultaneous estimation of Allopurinol and Alpha lipoic acid in bulk and pharmaceutical dosage form using C18 column (inertsil ODS, 250 x 4.6 mm, 5 μm) in isocratic mode. The mobile phase consisted of 0.1 M Dipotassium Phosphate buffer (pH 3.5) and acetonitrile in the ratio of 55:45v/v. The detection was carried out at 250 nm for Allopurinol and 212 nm for Alpha lipoic acid. The method was linear over the concentration range for Allopurinol 60–140 μg/ml and for Alpha lipoic acid 60–140μg/ml. The recoveries of Allopurinol and Alpha lipoic acid were found to be 98.9% and 98.7% respectively. The validation of method was carried out utilizing ICH-guidelines. The described HPLC method was successfully employed for the analysis of pharmaceutical formulations containing combined dosage form.