Aim: Clinical monitoring of oxcarbazepine (OXC) and its metabolite licarbazepine (MHD) in biological matrix requires a sensitive and validated analytical method. The aim of this study is to develop and validate an optimized ultra performance liquid chromatography-MS/MS based bioanalytical method for the simultaneous estimation of OXC and its metabolite MHD in human plasma, using deuterated internal standard method. Materials & methods: A reverse phase ultra performance liquid chromatography analysis and mass spectrometric detection was performed using electrospray ionization in positive ion mode as interface, multiple reaction monitoring as mode of acquisition. Results & conclusion: The linearity range was 10-4011 ng/ml for OXC and 40-16061 ng/ml for MHD. The kinetic parameters were calculated and compared for bioequivalence. This method fulfilled the validation guidelines, could be employed for determining bioavailability and in new formulation development studies.
Keywords: anti-epileptic drugs; bioanalytical method; bioequivalence; metabolite; oxcarbazepine; plasma.