高效液相色谱法测定人血浆中文拉法新浓度

Determination of the concentration of Venlafaxine in human plasma by HPLC

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。

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.