Stability-Indicating HPLC Method for the Determination of Oxcarbazepine in Pharmaceutical Formulation

Abstract

A simple, inexpensive and rapid stability indicating liquid chromatographic method has been developed for the quantitative determination of oxcarbazepine (OXC) in pharmaceutical formulation in presence of the degradation products. The separation was achieved by using an isocratic mobile phase consisting of the mixture of acetronitrile and water (50:50, v/v), using Hiber C₁₈ (250 mm × 4.6 mm, 5 μm) column at a flow rate of 1.0 mL/min. The detection was carried out at the wavelength of 256 nm. The retention time of oxcarbazepine was about 4.0 min and it shows an excellent linearity over a range of 0.05 to 80 μg/mL (r² = 0.999). The drug was exposed to thermal, photolytic, hydrolytic and oxidative stress conditions and the stressed samples were analyzed by the proposed method. The degredation products were well resolved from the main peak. The percentage of the recovery of drug has been ranged from 99.83 to 102.98 % in pharmaceutical dosage form. The developed method was validated with respect to linearity, accuracy, precision, specificity and robustness. Due to its simplicity and accuracy, the method can be used for routine analysis of oxcarbazepine in bulk drug and pharmaceutical formulations.