【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/WondaSilTMC18(4.6 mm×250 mm,5μm)色谱柱为固定相;以乙腈∶2 mmol/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1.0 mL/min;检测波长263 nm。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=0.741 903 42x-0.002 553 5(r2=0.999 26),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。更多还原

【Abstract】 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.更多还原