Abstract
A single high performance liquid chromatography (HPLC) method has been developed and validated for the quantitative estimation of Oxcarbazepine and its impurities (assays dissolution and related substances) in different type of dosage form. The chromatographic separation was performed on a Hypersil BDS C18 column with a particle size of 5µ (250X4.6 mm) and a mixture of 0.05M phosphate buffer adjusted to pH 6.0, methanol and acetonitrile in the ratio of 62:22:16 v/v/v as mobile phase at flow rate of 2.0 mL/minutes, Calibration showed that the response of impurity and drug substance was a linear function of concentration over the range 0.02–2.43 μgmL−1 (r2 ≥ 0.999) and the method was validated over this range for precision, intermediate precision, accuracy, linearity and specificity. For precision study, RSD of each impurity and drug substance was <5% and <2% respectively. The method was found to be precise, accurate, linear and specific. The proposed method was successfully employed for assay, dissolution and related substances analysis of Oxcarbazepine immediate release (IR), extended release (ER) tablets and suspension. A simple isocratic method with 35 minutes run time for determination of all three critical parameters is an added advantage of getting product quality in one shot.
