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作 者:任正[1] 姜宁玲[1] 王永庆[1] 陈安九[1] 吴德芹[1]
出 处:《药学与临床研究》2011年第5期472-474,共3页Pharmaceutical and Clinical Research
摘 要:目的:建立一种稳定可靠的HPLC-UV法测定血浆中雷贝拉唑的药物浓度。方法:以对羟基苯甲酸乙酯为内标,二氯甲烷-异丙醇(90∶10,V/V)为提取溶媒,流动相为0.1 mol.L-1醋酸铵(pH7.5)-乙腈-甲醇(64∶31∶5,V/V/V),检测波长290 nm。结果:在线性范围2.5~2030.0ng.mL-1内低、中、高浓度雷贝拉唑的回收率分别为:81.5%、80.7%、73.5%;低、中、高浓度的批内RSD分别为:8.2%、2.8%、4.2%;批间RSD分别为:10.5%、2.9%、3.8%。冻融试验结果表明低、中、高浓度的变异均小于10%。结论:此方法灵敏度高、稳定性好、特异性高、干扰少,可以很好地满足多种剂型雷贝拉唑药代动力学和生物等效性研究的要求。The aim of this study was to develop a stable and reliable method for the quantification of rabeprazole in human plasma.A reversed-phase high performance liquid chromatography(RP-HPLC) method with UV detection at 290 nm was carried out on a C18 column,using a mixture of ammonium acetate(0.1 mol·L-1,pH7.5),acetonitrile and methanol(64∶31∶5,V/V/V) as the mobile phase with the flow rate at 1.0 mL·min-1.The plasma samples were deproteinized with dichloromethane-isopropanol(90∶10).The method produced linear responses in the concentration range of 2.5~2030.0 ng·mL-1.The method was validated in terms of intra-and inter-batch precision(within 8.2% and 10.5%,respectively),accuracy,linearity,recovery and stability.The study showed that this HPLC method is sensitive and selective for the quantification of rabeprazole in human plasma.
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