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作 者:王广发[1] 陈清霞[2] 刘伟忠[3] 张嘉杰[1]
机构地区:[1]南方医科大学药学院,广州510515 [2]中山大学附属第二医院药学部,广州510120 [3]广州市脑科医院国家药品临床研究基地,510370
出 处:《医药导报》2010年第5期594-596,共3页Herald of Medicine
基 金:广州市粤港关键领域重点突破项目(基金编号:2006Z1-E6021)
摘 要:目的建立测定人血浆洛拉曲克浓度的反相高效液相色谱法。方法以DiamonsilTM C18反相柱(150 mm×4.6 mm, 5 μm)为色谱柱,流动相为0.03 mol·L-1醋酸铵-甲醇(40:60);流速:0.8 mL·min-1;柱温:40 ℃;检测波长: 233 nm。以乙酸乙酯与二氯甲烷(80:20)为提取剂。结果洛拉曲克的高、中、低(50.0, 10.0,1.0 μg·mL-1)3种浓度平均回收率分别为98.72%,97.86%,101.27%,日内、日间差RSD均<7%(n=5);分析方法的检测限为1.0 μg·mL-1;线性范围为1.0~50.0 μg·mL-1。标准曲线方程: Y=1.73X-5.29,r=0.999 8(n=8)。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。Objective To establish a method for determining the concentration of nolatrexed in human plasma by RP-HPLC. MethodsThe drug from plasma was analyzed in a RP-HPLC system: C18 column(150 mm×4.6 mm, 5 μm); mobile phase consisted of 0.03 mol·L-1 ammonioum-methanol(40:60); the flow rate at 0.8 mL·min-1; the detection wavelength at 233 nm. Ethyl acetate and dichloromethane(80:20) were used as extracting solvent. ResultsThe average recoveries of nolatrexed in high, middle and low concentrations (50.0, 10.0, 1.0 μg·mL-1) were 98.72% , 97.86% and 101.27%, respectively. The intra-day and inter-day variation(RSD)was less than 7% (n=5). The calibration curve of nolatrexed showed good linearity, r=0.999 8(n=8), over the range of 1.0-50.0 μg·mL-1. The regression equation was Y=1.73X-5.29. r=0.999 8(n=8). The minimum detectable concentration of nolatrexed was 1.0 μg·mL-1. ConclusionThe method is sensitive, accurate, easy and quick, which can be used for clinical drug monitoring and pharmacokinetics studies.
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