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目的 :建立反相HPLC测定人体中阿尼西坦血药浓度的方法。方法 :12名健康志愿者单剂量口服阿尼西坦 40 0mg后 ,用反相HPLC研究血中对甲氧基苯甲酰氨基丁酸 (PNBA)的浓度及代谢动力学过程 ,经 3P87软件处理数据。结果 :该方法经线性、精密性和准确度验证 ,日内变异系数 (n =5 )及日间变异系数 (n =6 )均在 10 %以内 ,检测限量为 0 .1μg/ml,Cmax达 17.5 μg/ml,Tmax为 2 3min ,AUC为 72 7(μg·min) /ml。 结论 :此方法的可靠性较好 ,比直接测定阿尼西坦浓度更方便 ,有实际意义。
Objective: To establish a reverse phase HPLC method for the determination of aniracetam plasma concentration in human. Methods: Twelve healthy volunteers were given a single oral dose of 40 mg of aniracetam. The concentrations of p-methoxybenzimidyl butyrate (PNBA) and its metabolic kinetics were determined by reversed-phase HPLC. The 3P87 software data. Results: The method was validated by linearity, precision and accuracy. The intra-day coefficient of variation (n = 5) and daytime coefficient of variation (n = 6) were within 10% with the detection limit of 0.1μg / ml and the Cmax of 17.5 μg / ml, Tmax 23 min, AUC 727 (μg · min) / ml. Conclusion: The reliability of this method is better than the direct determination of aniracetam concentration more convenient and practical.