一种用于中国志愿者中头孢泊肟测定及药代动力学研究的简易高效液相色谱法。
A simply HPLC method for determination of cefpodoxime in Chinese volunteer and pharmacokinetic study.
作者信息
Zhang J-h, Guo S, Xu M, Wu L-X
机构信息
Department of Pediatrics of Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai, China.
出版信息
Drug Res (Stuttg). 2013 Aug;63(8):435-8. doi: 10.1055/s-0033-1345149. Epub 2013 May 15.
A sensitive HPLC method was developed for the determination of cefpodoxime in human plasma. After protein precipitation with acetonitrile, sample was injected into the HPLC system for analysis. The chromatographic separation was carried out on a Diamonsil C18 column with a mobile phase consisting of acetonitrile-water. The mobile phase composed of water (containing 20 mmol/L monoammonium phosphate) and acetonitrile (90: 10, v/v). The detection wavelength was set at 254 nm. The standard curve for cefpodoxime was linear over the concentration range of 0.05-8 μg/mL with a lower limit of quantification of 0.05 μg/mL. The intra- and inter-day RSD values were lower than 10%, and the RE values were within±5%. For the pharmacokinetic analysis of plasma, the mean (SD) values obtained for the formulation were: Cmax, 4.21 (0.62) µg/mL; Tmax, 2.47 (0.61) h; t1/2, 2.38 (0.46) h; AUC0-24 h, 21.13 (3.39) µg/mL/h; and AUC0-∞, 23.34 (3.87) µg/mL/h; MRT, 2.21 (0.41) h, respectively.
建立了一种灵敏的高效液相色谱法用于测定人血浆中的头孢泊肟。用乙腈进行蛋白沉淀后，将样品注入高效液相色谱系统进行分析。色谱分离在Diamonsil C18柱上进行，流动相由乙腈 - 水组成。流动相由水（含20 mmol/L磷酸二氢铵）和乙腈（90:10，v/v）组成。检测波长设定为254 nm。头孢泊肟的标准曲线在0.05 - 8 μg/mL浓度范围内呈线性，定量下限为0.05 μg/mL。日内和日间相对标准偏差值低于10%，相对误差值在±5%以内。对于血浆的药代动力学分析，该制剂获得的均值（标准差）为：Cmax，4.21（0.62）μg/mL；Tmax，2.47（0.61）h；t1/2，2.38（0.46）h；AUC0 - 24 h，21.13（3.39）μg/mL/h；AUC0 - ∞，23.34（3.87）μg/mL/h；MRT，2.21（0.41）h。
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