DEVELOPMENT AND VALIDATION OF A STABILITY INDICATING RP-HPLC METHOD FOR THE DETERMINATION OF TERIZIDONE

A simple, rapid, sensitive, and linear stability indicating reverse phase HPLC method was developed for estimation of Terizidone. In this method separation was carried out on HiQSil C8 column (250mm*4.6 mm, 5μm) using Ammonium Acetate Buffer pH 3 (adjusted with glacial acetic acid) and methanol (60:40 v/v) as mobile phase at flow rate of 1 ml/min. The quantification was carried out at 264 nm. The retention time (tR) of drug was 7.3± 0.10 min. The method was validated with respect to linearity, precision, assay, accuracy and robustness. The data of linear regression analysis indicated a good linear relationship over the range of 5-30 μg/ml concentrations with a correlation coefficient (r 2 ) of 0.9837. Terizidone was subjected to different stress testing conditions. The degradation products were well resolved from the drug under the tested conditions. Keywords: Terizidone, High performance liquid chromatography, stability indicating method, validation