Журнал химических наук

Development and Validation of a UV-Spectrophotometric Method for the Quantitative Determination of Oxcarbazepine and Study of its Degradation Profile

Abstract

Deepakumari HN and Revanasiddappa HD

Oxcarbazepine (OXC) has attracted much attention owing to its multiple health benefits. OXC is an anticonvulsant and mood stabilizing drug, used primarily in the treatment of epilepsy. This study developed and validated a simple, specific, sensitive and reliable stability indicating UV-Spectrophotometric method for the quantitative determination of oxcrbazepine in pure and in pharmaceutical dosage forms. Analysis was performed using methanol: aceonitrile (50:50) as diluents. UV detection was performed at 254 nm. The calibration plot was linear over a concentration range of 0.0-15 μg ml-1 with correlation coefficient values >0.9986. The method was validated for specificity, linearity, precision, accuracy, limit of detection, limit of quantification and robustness. The forced degradation studies were performed by using HCl, NaOH, H2O2, thermal and UV radiation. Oxcarbazepine is more sensitive towards alkaline conditions and very much resistant towards acidic, oxidative and photolytic degradations. The method was validated as per ICH guidelines. The RSD for intra- and inter-day precision were found to be lesser than 3%. The percentage recovery was in good agreement with the labeled amount in the pharmaceutical formulations and the method is simple, specific, precise and accurate for the determination of oxcarbazepine in pharmaceutical formulations