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目的:建立反相高效液相色谱法测定血浆中阿莫西林浓度的方法。方法:色谱柱为Waters sunfire C_(18)色谱柱(150 mm×4.6 mm,5μm),流动相为0.05 mol·L~(-1)磷酸二氢钾溶液-乙腈(96.2:3.8),用磷酸调至pH=3.0,检测波长210 nm。结果:血样中阿莫西林的保留时间约为7.7 min,最低定量限为0.2μg·ml~(-1),在0.2～20.0μg·ml~(-1)范围内呈良好线性,平均方法学回收率为97.36%～99.21%,平均提取回收率为89.21%～92.05%,日内和日间RSD<5%。健康志愿者口服1.0 g阿莫西林后药动学参数C_(max)为(15.41±4.56)μg·ml~(-1);t_(1/2)为(1.24±0.20)h;t_(max)为(1.56±0.38)h;AUC_(0-8)为(47.69±12.25)μg·ml~(-1)·h;AUC_(0-∞)为(48.68±12.52)μg·ml~(-1)·h。结论:本方法稳定、快捷、灵敏,适用于阿莫西林制剂人体药物动力学研究。
Objective: To establish a method for the determination of amoxicillin in plasma by reversed-phase high performance liquid chromatography. METHODS: The chromatographic column was Waters sunfire C 18 column (150 mm × 4.6 mm, 5 μm). The mobile phase consisted of 0.05 mol·L -1 potassium dihydrogen phosphate solution - acetonitrile (96.2: 3.8) Adjust to pH = 3.0, detection wavelength 210 nm. Results: The retention time of amoxicillin in blood samples was about 7.7 min, the lowest limit of quantification was 0.2 μg · ml ~ (-1), and good linearity was found in the range of 0.2 ~ 20.0 μg · ml ~ (-1) The recoveries ranged from 97.36% to 99.21%. The average recoveries ranged from 89.21% to 92.05%. The intraday and interday RSDs were less than 5%. The pharmacokinetic parameters Cmax of healthy volunteers after oral administration of 1.0 g amoxicillin were (15.41 ± 4.56) μg · ml -1; t 1/2 (1.24 ± 0.20) h; t max ) Was (1.56 ± 0.38) h; the AUC_ (0-8) was (47.69 ± 12.25) μg · ml -1 · h; the AUC_ (0_∞) was 48.68 ± 12.52 μg · ml ~ 1) · h. Conclusion: The method is stable, rapid and sensitive and suitable for the study of human pharmacokinetics of amoxicillin preparation.