UPLC-MS/MS法测定硝苯地平缓释片在Beagle犬体内血药质量浓度  

Determination of plasma concentration of nifedipine sustained-release tablets in Beagle dogs using a UPLC-MS/MS

作　　者：崔保清 蔡翠芳[1] CUI Baoqing;CAI Cuifang(School of Pharmacy.Shenyang Pharmaceutical University,Shenyang 110016,China)

机构地区：[1]沈阳药科大学药学院,辽宁沈阳110016

出　　处：《沈阳药科大学学报》2020年第6期506-511,共6页Journal of Shenyang Pharmaceutical University

基　　金：国家自然科学基金资助项目(81502993)。

摘　　要：目的建立一种UPLC-MS/MS法,可以快速、准确测定Beagle犬体内硝苯地平的血药质量浓度。方法采用液液萃取法处理血浆样品,色谱柱为ACQUITY UPLC BEH C18色谱柱(50 mm×2.1 mm,1.7μm),流动相为乙腈与体积分数0.2%甲酸水溶液,线性梯度洗脱。质谱采用ESI源,在正离子模式下检测,扫描方式为多级反应监测方式。结果硝苯地平在0.2~100μg·L^-1内线性关系良好,定量下限为0.2μg·L^-1,日内、日间精密度RSD均小于15%,准确度为-5.33%~3.96%,提取回收率大于94%,基质效应在95.86%~99.58%内。硝苯地平缓释片在Beagle犬体内的药动学参数:t1/2为(3.55±4.04)h,ρmax为(46.14±18.46)μg·L^-1,tmax为(1.67±1.17)h,AUC(0-36)为(138.41±69.67)μg·L^-1·h,AUC(0-∞)为(143.28±67.77)μg·L^-1·h。结论该方法适用于硝苯地平血药质量浓度的测定。Objective To establish a UPLC-MS/MS method for rapid and accurate determination of the plasma concentration of nifedipine in Beagle dogs.Methods After plasma samples treated by liquid-liquid extraction,the nifedipine was separated on an ACQUITY UPLC BEH C18 column(50 mm×2.1 mm,1.7μm).The mobile phase was acetonitrile(A)and 0.2%formic acid in water(B)with gradient elution.Mass spectrometry analysis was performed using an ESI source in positive ion mode and the scanning mode was multiple reaction monitoring.Results The calibration curves were obtained over the range of 0.2-100μg·L-1 and the lower limit of quantitation was 0.2μg·L-1.The intra-day and inter-day precision were less than 15%and the accuracy was-5.33%-3.96%.The extraction recoveries were more than 94%and the matrix effects were between 95.86%and 99.58%.The pharmacokinetic parameters of nifedipine in Beagle dogs were as the followings,t1/2 was(3.55±4.04)h,ρmax was(46.14±18.46)μg·L-1,tmax was(1.67±1.17)h,AUC(0-36)was(138.41±69.67)μg·L-1·h,and AUC(0-∞)was(143.28±67.77)μg·L-1·h.Conclusion This method can be applied for the determination of plasma concentration of nifedipine in Beagle dogs.

关 键 词：硝苯地平 液质联用 药动学 

分 类 号：R917[医药卫生—药物分析学]