高效液相色谱法同时测定人血浆中富马酸喹硫平与度洛西汀浓度

目的 建立同时测定人血浆中喹硫平与度洛西汀浓度的高效液相色谱法.方法以DiamonsilTM C18反相柱（150mm＆#215;4.6mm,5μm）为色谱柱,流动相为30mmol·L-1醋酸铵-乙腈（18：82 V/V）;流速：1.0mL·min-1;柱温：40℃;检测波长：220nm.以乙酸乙酯和二氯甲烷（80：20 V/V）作为提取剂.结果 喹硫平在25.0～800.0μg·L-1、度洛西汀在10.0～320.0μg·L-1浓度范围内,峰面积与其浓度呈良好线性关系;喹硫平、度洛西汀的低、中、高3种浓度相对平均回收率大于95%;提取回收率大于70%.日内、日间RSD均低于15%（n=5）.分析方法的检测限5.0μg·L-1（S/N=3）;喹硫平曲线方程：Y=32.68X＋1.06,r=0.9989（n=7）;度洛西汀曲线方程：Y=21.39X＋1.72,r=0.9985（n=7）.结论 该方法灵敏、准确、简单、快速,可用于临床喹硫平与度洛西汀血药浓度监测和药动学研究.

Determination of the concentration of quetiapine Fumarate and duloxetine in human plasma by HPLC

OBJECTIVE To establish a method for determining the concentration of quetiapine and duloxetine in human plasma by HPLC. METHODS The drugs from plasma was analyzed in a reverse phase HPLC system C18 column （ 150mm × 4. 6mm, 5 μm） ; mobile phase consisted of 30mmol . L - 1 ammonioum-acetonitrile （ 18： 82） ; the flow rate was 1.0mL. min-1 ;the detection wavelength was at 220nm. Ethyl acetate and dichloromethane（80：20 V/V） was used as extracting solvent. RESULTS The calibration curves were linear in the range of 25.0 -800.0μg . L-1 for quetiapine, 10. 0 - 320. 0μg . L-1 for duloxetine respectively. The average recoveries of quetiapine and duloxetine in low ,middle and high concentrations over 95% respectively;the extraction recovery over 70% respectively. The in- tra-day and inter-day variation（RSD） was less than 15% （n = 5 ）. The minimum detectable concentration of quetiap- ine and duloxetine was 5.0μg . L-1 （ S/N = 3 ）. The calibration curve of quetiapine and duloxetine showed good line- arity,r = 0. 9989 and r = 0. 9985 （ n = 7 ） respectively. The regression equation of quetiapine was Y = 32. 68X ＋ 1.06and duloxetine was Y = 21.39X ＋ 1.72 respectively. CONCLUSION The method is sensitive, accurate, sim- ple and quick, it can be used for clinical drug monitoring and pharmacokinetics studies of quetiapine and duloxetine.