Development and 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
| Autor: | Chrysi Gabrieli, Vasilios K. Kimiskidis, Daniil Divanoglou, Ioannis Niopas, Feras Imad Kanaze, Marios Spanakis, Dimitrios Kazis |
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| Rok vydání: | 2006 |
| Předmět: |
Analyte
Acetonitriles Calibration curve Potassium Compounds Metabolite Coefficient of variation Clinical Biochemistry Analytical chemistry Pharmaceutical Science Oxcarbazepine Guidelines as Topic Buffers High-performance liquid chromatography Sensitivity and Specificity Analytical Chemistry Phosphates chemistry.chemical_compound Drug Discovery medicine Humans Amines Spectroscopy Biotransformation Chromatography High Pressure Liquid Bromazepam Chromatography Epilepsy Chemistry Reproducibility of Results Reference Standards Carbamazepine Calibration Linear Models Solvents Anticonvulsants Spectrophotometry Ultraviolet Drug Monitoring Quantitative analysis (chemistry) medicine.drug |
| Zdroj: | Journal of pharmaceutical and biomedical analysis. 43(2) |
| ISSN: | 0731-7085 |
| Popis: | 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 KH(2)PO(4), acetonitrile, and n-octylamine (76:24:0.05, v/v/v) at 40 degrees 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. |
| Databáze: | OpenAIRE |
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