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目的:建立以高效液相色谱法测定人血浆中阿伐斯汀浓度的方法,研究其在健康男性体内的药动学。方法:血浆样品经乙腈提取并浓缩后进样测定,外标法定量,色谱柱为Symmetry ShieldTM PR18,流动相为乙腈-2%三乙胺水溶液(用稀磷酸调节pH值至6.8±0.2)=25∶75,流速为1.0mL.min-1,柱温为35℃,紫外检测波长为250nm。结果:阿伐斯汀血药浓度在4.6875～600ng·mL-1范围内线性关系良好(r=0.9994);方法回收率为96.14%～98.89%,日内RSD=1.60%～3.00%,日间RSD=2.03%～6.98%;口服阿伐斯汀胶囊后的药-时数据符合一室药动学模型。结论:本方法简便、灵敏、准确、回收率高,适用于阿伐斯汀的血药浓度测定及临床药动学研究。
Objective: To establish a method for the determination of avastin in human plasma by high performance liquid chromatography (HPLC) and study its pharmacokinetics in healthy male volunteers. Methods: The plasma samples were extracted with acetonitrile and concentrated. The samples were determined by external standard method with Symmetry ShieldTM PR18 column. The mobile phase consisted of acetonitrile-2% triethylamine in water (pH adjusted to 6.8 ± 0.2 with dilute phosphoric acid) 25:75, the flow rate of 1.0mL.min-1, the column temperature of 35 ℃, UV detection wavelength of 250nm. Results: The linear range of avastin plasma concentration ranged from 4.6875 to 600 ng · mL-1 (r = 0.9994). The recovery rate was 96.14% -98.89%, and the intraday RSD was 1.60% -3.00%. The daytime RSD = 2.03% ~ 6.98%. The drug-time data of oral Avastin capsule accord with one-compartment pharmacokinetic model. Conclusion: The method is simple, sensitive, accurate, high recovery rate, suitable for determination of avastin plasma concentration and clinical pharmacokinetic studies.