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作 者:李荣[1] 黄婧[1] 卜凡龙[1] 袁桂艳[1] 魏春敏[1] 张蕊[1] 王本杰[1] 郭瑞臣[1]
机构地区:[1]山东大学齐鲁医院临床药理研究所,济南250012
出 处:《山东大学学报(医学版)》2013年第8期95-98,110,共5页Journal of Shandong University:Health Sciences
摘 要:目的建立人血浆阿昔莫司的定量分析方法,为药代动力学研究提供技术手段。方法采用高效液相色谱法,以Inertsil@/WondaSilTM C18(4.6mm×250mm,5μm)色谱柱为固定相;以乙腈:2mmol/L四丁基溴化铵(磷酸调pH值至3)=13:87(V/V)为流动相,咖啡因为内标。流速1.0mL/min;检测波长263nm。结果阿昔莫司在0.05~6μg/mL浓度范围内线性关系良好,标准曲线方程为Y=0.74190342x-0.0025535(r2=0.99926),最低定量限为0.05μg/mL,绝对回收率、精密度、准确度与稳定性均符合生物样本测定要求。结论本研究所建立方法专属性强,灵敏度高,精密度和准确度好,可用于阿昔莫司药代动力学研究。Objective To establish a quantified analytical method for the determination of acipimox in human plasma by HPLC-UV with caffeine as the internal standard. Methods Acipimox and caffeine in plasma were separated on a C18 reversed phase column after simple protein precipitation, eluted with mobile phase of acetonitrile-2 mmoL/L tetrabutyl ammonium bromide solution (pH = 3, 13: 87, V/V) at a flow rate of 1.0 mL/min, and detected at 263 nm. Results The calibration curve was linear ( r2 〉 0.99 ) over the concentration range of 0.05 - 6 μg/mL. The specificity, recovery, sensitivity, linearity, accuracy, precision, and stabilities were validated for acipimox in human plasma. Conclusion The established method is sensitive, specific and can successfully fulfill the requirements of acipimox pharmacokinetic studies.
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