HPLC-UV法测定人血浆及尿中多尼培南

发布时间：2018-07-25 06:52

【摘要】：建立HPLC-UV法测定人血浆及尿中多尼培南(DP)的质量浓度,用于DP人体药代动力学研究。采用Ultimate XB-C18(150 mm×4.6 mm×3μm)色谱柱,血浆及尿样测定用流动相分别为10 mmol/L醋酸钠∶乙腈∶三乙胺(体积比94∶6∶0.1,冰乙酸调p H为4.51)和8 mmol/L醋酸钠∶乙腈∶三乙胺(体积比95.5∶4.5∶0.1,冰乙酸调p H值为4.99),流速均为1 m L/min,检测波长为297 nm。血浆样品经乙睛沉淀蛋白,再用二氯甲烷反洗后取上清液进样,以美罗培南(MRP)做内标;尿样直接用水稀释后进样,外标法定量。血药浓度在0.0625~200μg/m L范围内与峰面积线性关系良好,定量限为0.0625μg/m L,批内精密度在1.0%~6.0%之间,批间精密度在3.0%~6.7%之间,方法回收率在92.4%~104.5%之间,预处理回收率在91.2%~103.8%之间。尿药浓度在0.625~4 800μg/m L范围内与峰面积线性关系良好,定量限为0.625μg/m L,批内精密度在0.7%~4.0%之间,批间精密度在1.1%~5.3%之间,方法回收率在94.1%~106.7%之间。该方法具有简便、灵敏、准确等特点,适用于人血浆及尿中多尼培南质量浓度的测定。
[Abstract]:A HPLC-UV method was established to determine the mass concentration of Donipenem (DP) in human plasma and urine. Ultimate XB-C18 (150mm 脳 4.6mm 脳 3 渭 m) column was used. The mobile phase for determination of plasma and urine samples was 10 mmol/L sodium acetate: acetonitrile: triethylamine (volume ratio 94: 6: 0.1, ice acetic acid adjusted pH = 4.51) and 8 mmol/L sodium acetate: acetonitrile: triethylamine (volume ratio 95.55: 4.5: 0.1, ice acetic acid p). H value is 4.99), flow rate is 1 mL / min, detection wavelength is 297 nm. The plasma samples were precipitated with ethylmethylene chloride, then the supernatant was injected with dichloromethane, and the (MRP) of meropenem was used as the internal standard, and the urine samples were diluted directly with water, and the external standard method was used to quantify the samples. The linear range of plasma drug concentration was 0.0625 渭 g / mL, the quantitative limit was 0.0625 渭 g / mL, the intra-assay precision was 1.0%, the inter-assay precision was between 3.0% and 6.7%, the recovery rate was between 92.4% and 104.5%, and the pretreatment recovery was between 91.22% and 103.8%. The linear range of urinary drug concentration was 0.625 ~ 4800 渭 g / mL, the quantitative limit was 0.625 渭 g / mL, the intra-assay precision was 0.7%, and the inter-assay precision was between 1.1% and 5.3%. The recovery rate of the method was 94.1% and 106.7%, respectively, in the range of 0.625 ~ 4.800 渭 g 路mL ~ (-1) 渭 g 路mL ~ (-1) 路ml ~ (-1) 路mL ~ (-1) 路mL ~ (-1). The method is simple, sensitive and accurate. It is suitable for the determination of Donipenem in human plasma and urine.
【作者单位】：四川大学华西医院临床药理研究室;成都中医药大学药学院;
【分类号】：R96

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