高效液相色谱法测定人血浆中文拉法新浓度

目的 建立测定人血浆中文拉法新浓度的高效液相色谱法.方法 以DiamonsilTM C18反相柱(150mm×4.6mm,5μm)为色谱柱,流动相为0.03mol·L-1醋酸铵-甲醇(19:81);流速:1.0mL·min-1;柱温:40℃;检测波长:254nm.以乙酸乙酯与二氯甲烷(80∶20)为提取剂.结果 文拉法新的低、中、高(20.0,160.0,640.0ng·mL-1)3种浓度平均相对回收率分别为101.32%,98.63%,99.61%,提取回收率分别为73.57%,76.85%,81.26%;日内、日间差RSD均低于10%(n=5);分析方法的检测限5.0ng·mL-1;线性范围为10.0～800.0ng·mL-1.线性方程:Y=22.75X+2.07,r=0.9989(n=8).结论 该方法灵敏、准确、简单、快速,可用于文拉法新临床血药浓度监测和药动学研究.

Determination of the concentration of Venlafaxine in human plasma by HPLC

OBJECTIVE To establish a method for determining the concentration of venlafaxine in human plasma by HPLC.METHODS The drug from plasma was analyzed in a reverse phase HPLC system C18 column(150 mm×4.6mm,5μm);mobile phase consisted of 0.03 mol·L-1 ammonioum-methanol(19:81);the flow rate was 1.0mL·min-1;the detection wavelength was at 254 nm.Ethyl acetate and dichloromethane(80∶20) was used as extracting solvent.RESULTS The average recoveries of venlafaxine in low,middle and high concentrations(20.0,160.0,640.0ng·mL-1) were 101.32%,98.63%and 99.61%,respectively.The intra-day and inter-day variation(RSD) was less than 10%(n=5).The calibration curve of venlafaxine showed good linearity,r=0.9989(n=8),over the range of 10.0~800.0ng·mL-1.The regression equation was Y=22.75X+2.07,r=0.9989(n=8).The minimum detectable concentration of venlafaxine was 5.0ng·mL-1.CONCLUSION The method is sensitive,accurate,simple and quick,it can be used for clinical drug monitoring and pharmacokinetics studies of venlafaxine.