HPLC法测定人血浆中阿托伐他汀的浓度及其药动学研究

Determination of Atorvastatin in Human Plasma by HPLC and Pharmacokinetics Study

目的:建立测定人血浆中阿托伐他汀片浓度的方法并考察其药动学。方法:选择20名男性健康志愿受试者,口服阿托伐他汀片10mg,采用高效液相色谱法测定血药浓度,计算药动学参数。结果:阿托伐他汀血药浓度在0.1～12.5μg·mL-1范围内线性关系良好,日内、日间RSD均<9%,方法回收率为89.00%～103.00%;阿托伐他汀的主要药动学参数为:t1/2(14.40±7.10)h,tmax(1.50±0.70)h,cmax(6.10±3.40)μg·L-1,AUC0～48h(50.60±43.60)μg·h·L-1,AUC0～∞(56.70±42.50)μg·h·L-1,MRT0～48h(3.68±0.75)h,MRT(3.82±0.71)h。结论:本方法适用于阿托伐他汀人体药动学的研究。

OBJECTIVE：To establish the method for the determination of atorvastatin in human plasma and study its pharmacokinetics.METHODS：20 male healthy volunteers were given Atorvastatin tablets 10 mg orally.The plasma concentration of atorvastatin was determined by HPLC,and pharmacokinetic parameters were measured.RESULTS：The linear range of atorvastatin were 0.1～12.5 μg·mL-1,the intra-day and inter-day RSD were all 9%,the recovery test result were 89.00%～103.00%.The main pharmacokinetic parameters of atorvastatin were as follow：t1/2（14.40±7.10）h,tmax（1.50±0.70）h,cmax（6.10±3.40）μg·L-1,AUC0～48 h（50.60±43.60）μg·h·L-1,AUC0～∞（56.70±42.50）μg·h·L-1,MRT0～48 h（3.68±0.75）h,MRT0～∞（3.82±0.71）h.CONCLUSION：The method is suitable for pharmacokinetic study of atorvastatin in healthy volunteer.