HPLC法测人血浆对乙酰氨基酚浓度及其药代动力学研究

Determination of Paracetamol in human plasma by HPLC and its pharmacokinetic studies

目的建立HPLC法测人血浆中对乙酰氨基酚浓度，并进行药代动力学研究。方法血浆样品采用液-液萃取法萃取，UltimateTM XB-C18（250mm×4．6mm，5μm）色谱柱分离；流动相为乙腈：水（10：90，V／V），流速：1．0mL·min^-1；检测波长237nm。结果对乙酰氨基酚血药质量浓度在0．025～25μg·mL^-1内的线性关系良好（r=0．9989），血浆中低、中、高3种浓度（0．05，5，20μg·mL^-1）的相对回收率在92．9％～92．1％之间；日内RSD≤5．77％，日间RSD≤4．24％。结论本法操作简便、准确、灵敏，适用于乙酰氨基酚的药动学研究。

OBJECTIVE To develop a HPLC method for determination of paracetamol in human plasma,and investigate its pharmacokinetic characteristics in healthy volunteers, METHODS The plasma sample was liquid-liquid extracted, separated on a UltimateTM XB-C18 （250mm×4. 6mm,5μm）analytical column with mobile phase of acetonitrile-water（10 ： 90） at a flow rate of 1, 0ml · min^-1 and the detection occurred at 237 nm, RESULTS The excellent linearity was obtained in the range of 0. 025 ～ 25μg · mL^-1 （ r= 09989）. The relative recoveries of low, medium and high concentrations （0. 05,5,20μg · mL^-1 ） were within 92. 9 % ～ 92.1%. The intra-day and inter-day RSD were not more than 5.77 % and 4.24 %, respectively. CONCLUSION The analysis method is simple,accurate,sensitive and suitable for paracetamol pharmacokinetic studies.