血浆中头孢泊肟的高效液相色谱法分析及其药代动力学研究

HPLC determination and pharmacokinetics study of cefpodoxime in human plasma

目的:建立人体血浆中头孢泊肟的 HPLC 分析方法,并对其在人体内的药代动力学进行研究。方法:以 C_(18)固相萃取小柱提取纯化血样。采用反相高效液相色谱分析法测定头孢泊肟的浓度。流动相:乙腈-10 mmoL·L^(-1)乙酸钠(20:80,pH=3.05);色谱柱:迪马 ODS 色谱柱(4.6 mm×150 mm,5μm);柱温:40 ℃;流速:1.0 mL·min^(-1);检测波长:295 nm。结果:头孢泊肟在0.1～6.4 mg·L^(-1)血浆浓度范围内线性关系良好(r=0.9996),最低检测浓度为0.1 mg·L^(-1);0.2,0.8,3.2 mg·L^(-1)3种浓度的日内、日间 RSD(n=5)分别为2.6%～5.0%和2.6%～4.3%;绝对回收率平均为77.06%,相对回收率平均为98.68%。结论:该方法简便灵敏、重现性好,能满足药代动力学和生物等效性研究的需要。

Objective：To establish an HPLC method for determination of cefpodoxime to study the pharmacokinetics and bioequivalence of cefpodoxime proxetil in healthy volunteers. Methods： The cefpodoxime was extracted from the plasma with a solid - phase extraction column, and determined by high - performance liquid chromatography at 295 nm. The mobile phase was acetonitrile -sodium acetate（20： 80,pH =3.05） with the flow rate of 1.0 mL ·min^-1 The column was Diamonsil ODS（4. 6 mm × 150 mm,5 μm） ,the column temperature was 40℃. Results：The com- pounds were allowed determination of 0. 1 -6.4 mL ·min^-1 of cefpodoxime in human plasma with reproducibility（ r = 0. 9996）. The limit of detection was 0. 1 mL ·min^-1. Intra - day and inter - day RSD for assaying the plasma sample containing three concentration of cefpodoxime were 2.6% - 5.0% and 2. 6% - 4. 3% （ n = 5 ）, respectively. The mean absolute recovery was 77.06% and the mean relative recovery was 98.68%. Conclusion：The proposed method is simple, sensitive and reproducible.