Development and validation of an HPLC-UV method for the simultaneous quantification of carbamazepine, oxcarbazepine, eslicarbazepine acetate and their main metabolites in human plasma |
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Authors: | Ana Fortuna Joana Sousa Gilberto Alves Amílcar Falcão Patrício Soares-da-Silva |
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Institution: | 1. Pharmacology Department, Faculty of Pharmacy, University of Coimbra, 3000-548, Coimbra, Portugal 2. Centre for Neurosciences and Cell Biology, University of Coimbra, 3004-517, Coimbra, Portugal 3. Health Sciences Research Centre, University of Beira Interior, 6200-506, Covilh?, Portugal 5. Pharmacology Department, Faculty of Pharmacy, University of Coimbra, Pólo das Ciências da Saúde, Azinhaga de Santa Comba, 3000-548, Coimbra, Portugal 4. Department of Research and Development, BIAL, 4745-457, S. Mamede do Coronado, Portugal
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Abstract: | For the first time, a simple, selective and accurate high-performance liquid chromatography method with ultraviolet detection
was developed and validated to quantify simultaneously three structurally related antiepileptic drugs; carbamazepine, oxcarbazepine,
and the recently launched eslicarbazepine acetate and their main metabolites, carbamazepine-10,11-epoxide, 10,11-trans-dihydroxy-10,11-dihydro-carbamazepine, and licarbazepine. The method involves a solid-phase extraction and a reverse-phase
C18 column with 5 cm length. The mobile phase consisting of water, methanol, and acetonitrile in the ratio 64:30:6 was selected
as the best one and pumped at 1 mL/min at 40 °C. The use of this recent column and an aqueous mobile phase instead of buffers
gives several advantages over the method herein developed; namely the fact that the chromatographic analysis takes only 9 min.
The method was validated according to the guidelines of the Food and Drug Administration, showing to be accurate (bias within
±12%), precise (coefficient variation <9%), selective and linear (r
2 > 0.997) over the concentration range of 0.05–30 μg/mL for carbamazepine; 0.05–20 μg/mL for oxcarbazepine; 0.15–4 μg/mL for
eslicarbazepine acetate; 0.1–30 μg/mL for carbamazepine-10,11-epoxide; 0.1–10 μg/mL for 10,11-trans-dihydroxy-10,11-dihydro-carbamazepine, and 0.1–60 μg/mL for licarbazepine. It was also shown that this method can adequately
be used for the therapeutic drug monitoring of the considered antiepileptic drugs, carbamazepine, oxcarbazepine, eslicarazepine
acetate, and their metabolites. |
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