Analysis of carbamazepine and its active metabolite, carbamazepine-10,11-epoxide, in human plasma using high-performance liquid chromatography |
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Authors: | Eun kyung Oh Eunmi Ban Jong Soo Woo Chong-Kook Kim |
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Institution: | (1) Laboratory of Excellency for Drug and Gene Delivery, College of Pharmacy, Seoul National University, San 56-1, Shillim-dong, Kwanak-gu, Seoul, 151-742, South Korea;(2) Hanmi Pharm Co., Ltd., 893-5, Hajeo-ri, Paltan-myeon, Hwasung-si, Gyeonggi-do, South Korea |
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Abstract: | A sensitive method based on high-performance liquid chromatography (HPLC) with ultraviolet (UV) detection was developed for
the determination of carbamazepine (CBZ) and one of its active metabolites, carbamazepine-10,11-epoxide (CBZ-E) in human plasma.
CBZ, CBZ-E and the internal standard (IS) 10,11-dihydrocarbamazepine were extracted from human plasma into methyl tert-butyl ether. CBZ, CBZ-E and the IS were successfully separated on an RP C18 column with a mobile phase of acetonitrile:methanol:water
(18:19:63, v/v/v) and monitored via UV detection at 210 nm. The calibration curves were linear over the concentration ranges
of 0.01–10 μg/mL for CBZ and 0.005–5 μg/mL for CBZ-E in human plasma, respectively. The method displayed excellent sensitivity,
precision and accuracy, and was successfully applied to the quantification of CBZ and CBZ-E in human plasma after oral administration
of a single 200 mg CBZ CR tablet. This method is suitable for bioequivalence studies following single doses given to healthy
volunteers. |
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Keywords: | Carbamazepine Carbamazepine-10 11-epoxide High-performance liquid chromatography (HPLC) Bioequivalence study |
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