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Development and Validation of Spectrophotometric Methods for Estimation of Zileuton in Bulk and its Dosage Form

K. Vara Prasada Rao, M. Tanuja, Y. Srinivasa Rao and T. Hemant Kumar

Two simple and sensitive visible spectrophotometric methods were developed for the estimation of zileuton in bulk and tablet dosage form. Method A is based on the oxidation of zileuton with ferric chloride followed by complex formation with potassium ferricyanide that is a green coloured complex, which shows maximum absorption at 710 nm and obeys Beer’s law in the concentration range of 0.5-3 μg/mL. In method B zileuton reacts with hetero polyacid Folin-Ciocalteu reagent (FC) in presence of alkaline condition undergoes reduction and converts to molybdenum blue having absorption maxima at 727 nm and obeys Beer’s law in the concentration range of 1-4 μg/mL. The proposed methods were simple, sensitive and accurate for routine quality control of zileuton in bulk and pharmaceutical formulation.