人血浆中富马酸奎硫平浓度的测定

Determination of quetiapine fumarate in blood plasma

目的:建立测定人血浆中富马酸奎硫平(QTP)浓度的HPLC法。方法:以Diamonsil^(TM)C_(18)柱(250mm×4.6mm,5μm)为色谱柱,流动相:甲醇-超纯水(85:15,V/V),流速为0.8mL·min^(-1),检测波长254nm,以乙酸乙酯为提取剂。结果:QTP 80.00,16.67,1.67μg·mL^(-1)高、中、低3个浓度的平均回收率分别为98.20％,101.44%,98.21％。日内、日间RSD均<5%(n=5)。分析方法的最小检测限为0.08μg·mL^(-1)(r_(SN)=2)。线性范围为0.17～100.00μg·mL^(-1),线性回归方程为Y=8.78×10^(-2)X-3.37×10^(-2),r=0.9999(n=11)。结论:该方法灵敏、准确、简单、快速,可用于临床血药浓度监测和药动学研究。

AIM: To develop an HPLC method for quantitative determination of quetiapine fumarate (QTP) in blood plasma. METHODS: QTP were extracted with ethyl acetate. The residues dissolved were analyzed with a reverse phase HPLC system (C18 column, 250 mm×4.6 mm, 5 μm); mobile phase: MeOH-H2O (85:15, V/V); UV detection: 254 run. RESULTS: The average recoveries for QTP were 98.20% , 101.44% and 98.21% for 3 concentrations, respectively. The within-day and between-day RSD was lower than 5% (n=5). The calibration curves for QTP had good linearity, r = 0.999 9 ( n = 11) within a concentration range of 0.17 - 100.00 μg·mL-1. The limits of quantiation for QTP were 0.08 μg·mL-1( rSN = 2). CONCLUSION: The method provides a sensitive, accurate, precise and reliable analytical procedure for clinical monitoring of QTP in blood plasma and its phamacokinetic studies.