高效液相色谱-质谱法测定人血浆中硝苯地平的浓度  

Determination of nifedipine in human plasma by HPLC-MS and its application to pharmacokinetics study

作　　者：马爱玲[1] 廉建伟[1] 毕开顺[1] 陈晓辉[1] 

机构地区：[1]沈阳药科大学药学院,辽宁沈阳110016

出　　处：《中国医院药学杂志》2008年第24期2103-2105,共3页Chinese Journal of Hospital Pharmacy

摘　　要：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 concentration in human plasma by HPLCMS. METHODS Plasma concentration of nifedipine were determined by HPLC MS method using diazepam as internal standard. The mobile phase consisted of acetonitrile-water （60：40） and detection was performed on a single quadrupole mass spectrometer in positive selected ion monitering （SIM） mode via electrospray ion （ESI） source. The plasma concentration and pharmacokinetics were measured and calculated. RESULTS The linear range of nifedipine was 1-200ug· L^- 1. The intra day and inter day precision of nifedipine were 〈 15 %. The extraction recovery of nifedipine at 2.0,25.0 and 160 ug· L^-1 were 74. 1% , 82. 5% and 87. 6% , respectively. The pharmacokinetic parameters of nifedipine were as follows： tmax = （2. 2 ±0. 8）h, Cmax = （ 71.1 ± 18.6 ） ng· mL^-1 , t1/2 = （ 6.2 ± 3.4） h, AUC0-36 = （ 366. 0 ± 141.4）ug· h · L^ -1 , AUC0-∞ = （395.9± 176. 8 ）ug· h· L^ -1. CONCLUSION HPLC MS method is selective, sensitive and convenient, proved to be applicable to determine the concentration of nifedipine in human plasma and for its pharmacokinetics study.

关 键 词：硝苯地平 缓释片 高效液相色谱法 质谱 电喷雾离子化源 药动学 

分 类 号：R969.1[医药卫生—药理学]