Conway Jeannine M, Birnbaum Angela K, Marino Susan E, Cloyd James C, Remmel Rory P
Experimental and Clinical Pharmacology, College of Pharmacy, University of Minnesota, Minneapolis, MN, USA.
Biomed Chromatogr. 2012 Sep;26(9):1071-6. doi: 10.1002/bmc.1749. Epub 2012 Jan 4.
Topiramate (Topamax®) is an antiepileptic medication used as adjunctive and monotherapy in patients with epilepsy and for migraine prophylaxis. A GC-MS assay was developed that was capable of detecting topiramate plasma concentrations following a single rectal or oral dose administration. Topiramate plasma samples were prepared by solid-phase extraction and were quantified by GC-MS analysis. The topiramate standard curves were split from 0.1 to 4 µg/mL and from 4 to 40 µg/mL in order to give a more accurate determination of the topiramate concentration. The accuracy of the standards ranged from 94.6 to 107.3% and the precision (%CV) ranged from 1.0 to 5.3% for both curves at all concentrations. The %CV for quality controls was <7.6%. The assay is both accurate and precise and will be used to complete future pharmacokinetic studies.
托吡酯(妥泰®)是一种抗癫痫药物,用于癫痫患者的辅助治疗和单药治疗以及偏头痛预防。开发了一种气相色谱 - 质谱(GC - MS)测定法,该方法能够检测单次直肠或口服给药后的托吡酯血浆浓度。托吡酯血浆样品通过固相萃取制备,并通过GC - MS分析进行定量。托吡酯标准曲线在0.1至4μg/mL和4至40μg/mL范围内进行分段,以便更准确地测定托吡酯浓度。所有浓度下,两条曲线的标准品准确度范围为94.6%至107.3%,精密度(%CV)范围为1.0%至5.3%。质量控制的%CV<7.6%。该测定法既准确又精密,将用于完成未来的药代动力学研究。