Volumetric and spectrophotometric determination of oxcarbazepine in tablets

Abstract

Two cerimetric procedures are described for the assay of oxcarbazepine (OXC) in bulk drug and in tablets. Titrimetry (method A) is based on the reaction of OXC by a measured excess cerium(IV) sulphate in sulphuric acid medium and the determination of the unreacted oxidant by titration with iron(II) solution using ferroin as indicator. Spectrophotometry (method B) is based on oxidation of OXC by cerium(IV) in perchloric acid (HClO4) medium and the determination of the unreacted oxidant using a colour reaction with p-dimethylaminobenzaldehyde (p-DMAB) having an absorption maximum of 460 nm. The titrimetric method is applicable in the range of 2.0-20.0 mg OXC with a 1:2 reaction stoichiometry [OXC:Ce(IV)]. In the spectrophotometric method a rectilinear relationship is obtained over the concentration range of 0.3-6.0 µg mL-1 OXC. The linear regression equation of the calibration graph is A = 0.9820-0.1477 C with a regression coefficient (r) of -0.9967 (n = 6). The molar absorptivity is calculated to be 3.76 × 104 L mol-1 cm-1 and the Sandell sensitivity is 0.0067 µg cm-2. The limits of detection (LOD) and quantification (LOQ) values are calculated according to ICH guidelines. The methods are successfully applied to the determination of OXC in tablets.