高效液相色谱法测定人血浆中硝苯地平的浓度

High performance liquid chromatographic assay for the nifedipine in human plasma

目的:建立高效液相色谱法测定人血浆中硝苯地平的浓度.方法:分析柱为Micro Pah C 18分析柱.流动相为甲醇:水:冰乙酸:正丁胺(77:23:0.02:O.01).检测波长为235nm.采取乙醚二次萃取法提取血浆中的硝苯地平及内标安定.结果:测定硝苯地平的日内及日间精密度的RSD均小于10%.血药浓度在6.16～197.20 ng/ml范围内线性关系良好(r=0.9994).最低检测限为2ng/ml.结论:本方法适用于硝苯地平的药物动力学研究.

AIM: To establish high performance liquid chromatography for the determina-tion of nifedipine in human plasma. METHODS: Separation of nifedipine and internal standard,diazepam, was obtained using Micro Pak C 18 analysis column. The detection was done at 235 nm. The mobile phase consisted of methanol-water-acetic acid-buthylamine(77 : 23 : 0.02 : 0. 0l, V/V). They were extracted from plasma with diethyl ether. RESULTS: The relative standard deviation (RSD)of within-day and day-to-day were less than 10%. Calibration was linear from 6. 16 to 197. 20 ng/ml(r=0. 999 4). The limit of detection was 2 ng/ml. CONCLUSION: This method has been demonstrated to be suitable for pharma-cokinetic study.