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HPLC法测定5种抗癫痫药及其代谢物的血浆分析方法的建立:与免疫分析法的比较

摘要

随着生物分析在药物发现和开发过程中成为一种关键工具，人们希望有更便宜、更快和更简单的分析方法来支持药物相互作用筛选研究，并在大浓度范围内进行统计验证，本工作的目的是开发一种简单的、快速高效液相色谱法同时定量临床常用的6种抗癫痫药物(苯巴比妥、拉莫三嗪、奥卡巴西平、单羟基卡巴西平、卡马西平、苯妥英)人血浆浓度。以氯硝西泮为内标。样品制备包括乙腈脱蛋白步骤。提取后，在C18反相色谱柱上分离，温度为25℃。流动相由50%磷酸盐缓冲液(pH=7.5)和50%甲醇/乙腈(80:20,v/v)组成，以1ml /min等压泵送。紫外检测器设置在215 nm。总运行时间仅为10 min，提取率在84% ~ 99%之间。所有这些抗癫痫药物都以良好的峰形和大于2的分辨率分离。该方法简便、快速。 Calibration curves were linear with regression coefficients greater than 0.998. Intraand interday precision CV% varied between 0.91% and 5.69%. Bias value for accuracy ranged from 2.42% to 1.27%. The mean absolute extraction recoveries at low, middle and high quality control sample levels ranged from 84.17% to 99.02%. This bioanalytical method was successfully applied to real plasma samples from 26 epileptic patients. Our results were compared to those obtained by immunoassay methods in biochemistry-toxicology FATTOUMA hospital laboratory and in Tunisia Pharmacovigilance Center. The developed method seems to be a suitable tool for routine therapeutic drug monitoring and also to support other clinical pharmacokinetic-based studies.

Kaouthar Louati, Sarah Mahfoudhi和Fathi Safta

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