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目的:建立高效液相色谱-质谱(HPLC-MS)法测定血浆中硝苯地平的方法。方法:采用HPLC-MS法,以地西泮为内标物,选择正离子检测的电喷雾离子化源,以乙腈-水(60∶40)为流动相,测定硝苯地平的浓度,计算药动学参数。结果:硝苯地平在1～200μg·L-1范围内线性关系良好,最低定量限浓度为1μg·L-1,日内、日间RSD均小于15%,硝苯地平在低、中、高3个浓度时的血浆样品提取回收率分别为74.1%,82.5%和87.6%。健康志愿者口服硝苯地平缓释片后主要药动学参数tmax为(2.2±0.8)h,Cmax为(71.1±18.6)μg·L-1,t1/2为(6.2±3.4)h,AUC0-36为(366.0±141.4)μg·h·L-1,AUC0-∞为(395.9±176.8)μg·h·L-1。结论:该方法选择性强,灵敏度高,操作简便,适用于临床血药浓度监测及药动学的研究。
Objective: To establish a method for the determination of nifedipine in plasma by high performance liquid chromatography-mass spectrometry (HPLC-MS). Methods: HPLC-MS was used to determine the concentration of nifedipine by using acetonitrile-water (60:40) as mobile phase with the positive ion electrospray ionization with diazepam as internal standard. Dynamic parameters. Results: Nifedipine showed a good linearity in the range of 1 ~ 200μg · L-1 with the lowest limit of quantification of 1μg · L-1, RSD less than 15% in the day and in the day, and nifedipine in the low, middle and high 3 The concentration of plasma samples at the time of extraction recovery were 74.1%, 82.5% and 87.6%. The pharmacokinetic parameters tmax of healthy volunteers after oral administration of nifedipine were (2.2 ± 0.8) h, Cmax was (71.1 ± 18.6) μg · L-1, t1 / 2 was (6.2 ± 3.4) -36 was (366.0 ± 141.4) μg · h · L-1 and AUC0-∞ was (395.9 ± 176.8) μg · h · L-1. Conclusion: This method is selective, sensitive and easy to operate. It is suitable for the monitoring of clinical plasma concentration and pharmacokinetics.