STABILITY INDICATING RP-HPLC METHOD FOR DETERMINATION OF MODAFINIL IN BULK & ITS FORMULATIONS
A simple, rapid and accurate stability indicating RP-HPLC method was developed for the determination of Modafinil in pure and tablet forms. The method was carried out using Phenomenex ODS C-18 column (250 x 4.6 mm, packed with 5 micron) using 0.2 % acetic acid in methanol and water (90:10, v/v), pH 4.0 as the mobile phase with detection at 225 nm and a flow rate of 0.5 ml/min. The retention time was found to be 6.10 min. The responses were linear in concentrations range of 10- 100µg/ml with correlation coefficient of 0.999. The method was statistically validated for accuracy, precision, linearity, intra and interday assay, ruggedness and robustness. The percentage recovery was found to be between 98.94-100.12% and % RSD from recovery studies was found to be less than 1. Commercial tablets containing 100mg and 200mg of Modafinil were analyzed by the proposed method and the results were well within the claimed limits. Furthermore stability studies of Modafinil were carried out under various stress conditions as per SIAM (Stability Indicating Assay Methods).