RP-HPLC METHOD FOR THE ESTIMATION OF ZILEUTON IN TABLET FORMULATION

A simple, rapid, accurate and precise RP-HPLC method was developed and validated for the determination of zileuton in table dosage form. Chromatographic analysis of the drug was achieved on Cyberlab HPLC comprising of LC- 100P pump, a variable wavelength programmable LC-UV100 UV detector and SCL system controller. Flowrosil C18 column (250 mm x 4.6 mm, 5 μ) as stationary phase with mobile phase consisting of Methanol: Acetonitrile: 1% GAA in the ratio of 70:10:20 v/v. The method showed a good linear response in the concentration range of 5-30 μg/ml with correlation coefficient of 0.9993. The flow rate was maintained at 1.0 ml/min and detection was carried out at 230 nm. The retention time was 3.12 min. The method was statistically validated for accuracy, precision, linearity, ruggedness, robustness, solution stability, selectivity and sensitivity. The results obtained in the study were within the limits of ICH guidelines and hence this method can be used for the determination of zileuton in tablet formulation.