Oxcarbazepine

7413's picture

Development ãnd Validation of a High Performance ‎Liquid Chromatographic Method for the Determination ‎of Oxcarbazepine and its Main Metabolites in Human ‎Plasma and Cerebrospinal Fluid and its Application ‎to Pharmacokinetic Study

Journal Title, Volume, Page: 
Journal of Pharmaceutical and Biomedical Analysis Volume 43, Issue 2, Pages 763–768
Year of Publication: 
2007
Authors: 
Feras Imad Kanaze
Department of Pharmacy, Aristotle University of Thessaloniki, 54124 Thessaloniki, Greece
Current Affiliation: 
Department of Pharmacy,Faculty of Medicine & Health Sciences, An-Najah National University, Nablus, Palestine
Vasilios Kimiskidis
3rd Department of Neurology, George Papanicolaou Hospital, Aristotle University of Thessaloniki, Greece
Marios Spanakis
Department of Pharmacy, Aristotle University of Thessaloniki, 54124 Thessaloniki, Greece
Ioannis Niopas
Department of Pharmacy, Aristotle University of Thessaloniki, 54124 Thessaloniki, Greece
Dimitrios Kazis
3rd Department of Neurology, George Papanicolaou Hospital, Aristotle University of Thessaloniki, Greece
Chrysi Gabrieli
Department of Pharmacy, Aristotle University of Thessaloniki, 54124 Thessaloniki, Greece
Daniil Divanoglou
3rd Department of Neurology, George Papanicolaou Hospital, Aristotle University of Thessaloniki, Greece
Preferred Abstract (Original): 

An isocratic reversed-phase HPLC-UV procedure for the determination of oxcarbazepine and its main metabolites 10-hydroxy-10,11-dihydrocarbamazepine and 10,11-dihydroxy-trans-10,11-dihydrocarbamazepine in human plasma and cerebrospinal fluid has been developed and validated. After addition of bromazepam as internal standard, the analytes were isolated from plasma and cerebrospinal fluid by liquid–liquid extraction. Separation was achieved on a X-TERRA C18 column using a mobile phase composed of 20 mM KH2PO4, acetonitrile, and n-octylamine (76:24:0.05, v/v/v) at 40 °C and detected at 237 nm. The described assay was validated in terms of linearity, accuracy, precision, recovery and lower limit of quantification according to the FDA validation guidelines. Calibration curves were linear with a coefficient of variation (r) greater than 0.998. Accuracy ranged from 92.3% to 106.0% and precision was between 2.3% and 8.2%. The method has been applied to plasma and cerebrospinal fluid samples obtained from patients treated with oxcarbazepine, both in monotherapy and adjunctive therapy.

Syndicate content