用HPLC法测定人血浆中头孢吡肟的浓度

Determination of the content of cefepime in human plasma by HPLC method

目的:建立测定人血浆中头孢吡肟浓度的HPLC法。方法:色谱柱为Kromasil C_(18)柱(250 mm×4．6 mm, 5μm),流动相为甲醇-乙腈-水(5:4:91),流速1．0 mL/min,检测波长254 nm。以对乙酰氨基酚为内标,血浆样品用高氯酸沉淀蛋白质后取上清液进样分析。结果:头孢毗肟峰面积与血药浓度在1．0～200．0μg/mL范围内线性关系良好(r=0．9999)。日内RSD＜6％(n=5),日间RSD＜10％(n=5)。低、中、高3种浓度(2．0、50．0、150．0μg/mL)的方法回收率分别为(111．33±2．36)％、(100．95±0．51)％和(98．50±0．91)％,提取回收率分别为(104．21±2．15)％、(96．67±0．49)％和(94．72±0．87)％。结论:本方法简便、快速、准确、精密度好,可用于头孢吡肟的临床药动学研究。

Objective： To establish a HPLC method for the quantitative determination of cefepime in human plasma. Methods： The HPLC separation was performed on Kromasil C18 column （250 mm×4.6mm,5μm）. The mobile phase was methanol-acetonitrile-water （5 ： 4 ： 91） with a flow rate of 1.0 mL/min. The detection wavelength was 254 nm. Paracetamol was used as internal standard and plasma samples were deproteinized with perchloric acid. Results： The concentrations of cefepime were in good linearity within the range of 1.0-200.0μg/mL（r=0. 999 9）. The intra-day RSD did not exceed 6% and the inter-day RSD did not exceed 10% （n= 5）. The method recovery rates and extraction recovery rates at low, middle and high concentrations of cefepime （2.0, 50.0, 150.0 μg/mL） were （111.33±2. 365 %,（100.95±0. 515% and （98. 50±0.91）% and （104.21±2.15）% ,（96.67±0.49）% and （94.72±0.87） % ,respectively. Conclusion： This method is simple, rapid,accurate and precise. It is suitable for clinical pharmacokinetics study of cefepime.