Method Development and Validation for Determination of Oxcarbazepine In Oxcarpazepine Raw Material and Pharmaceutical Dosage Form Using Reversed-phase Liquid Chromatography

ABSTRACT: A simple, accurate and precise stability-indicating HPLC method was developed and validated to assay oxcarbazepine in oxcarbazepine raw material and in its tablets. The separation was conducted under isothermal elution at a flow rate of 1.0 mL/min. It was performed on a Thermo, Hypersil C18 (250 mm x 4.6 mm, 5 µm) column with a mobile phase consisted of 23% acetonitrile and 77% buffer solution containing 25 mM potassium mono basic phosphate adjusted at pH 2.9. The column temperature was controlled at 25^oC and the absorption wavelength was set at 257 nm.

The developed method was validated in terms of linearity, specificity, accuracy, precision and robustness under both ICH and FDA guidelines. The proposed method was found suitable to determine the potential degradants resulted when oxcarbazepine active ingredient was subjected to various stress conditions of acid and base hydrolysis, peroxide oxidation, heat and light.