Muth P, Metz R, Beck H, Bolten W W, Vergin H
Medical Biological Development, Heumann Pharma, Nürnberg, Germany.
J Chromatogr A. 1996 Apr 5;729(1-2):259-66. doi: 10.1016/0021-9673(95)01021-1.
A highly sensitive and selective HPLC method was developed for the determination of amoxicillin in human plasma. After addition of buffer and internal standard, the sample was ultrafiltered and injected on to a precolumn to remove polar plasma interferences. Detection was effected with a UV detector set at 230 nm. The limit of quantification for amoxicillin was 50.1 ng/ml with an imprecision of 4.2% using 0.25 ml of plasma. Linearity was confirmed over the whole calibration range (25.4-0.0501 micrograms/ml) and the inter-day variation ranged from 2.0 to 4.5%. The method was validated according to GLP guidelines and its suitability was demonstrated by the analysis of several hundred samples in a bioequivalence study. The method can be used to determine pharmacokinetic parameters of amoxicillin in humans after a single oral dose of 500 mg.
建立了一种高灵敏度和高选择性的HPLC方法，用于测定人血浆中的阿莫西林。加入缓冲液和内标后，对样品进行超滤并注入预柱以去除极性血浆干扰物。使用设置在230 nm的紫外检测器进行检测。阿莫西林的定量限为50.1 ng/ml，使用0.25 ml血浆时的不精密度为4.2%。在整个校准范围内（25.4 - 0.0501微克/毫升）均确认了线性，日间变化范围为2.0%至4.5%。该方法按照GLP指南进行了验证，并且在一项生物等效性研究中通过对数百个样品的分析证明了其适用性。该方法可用于测定单次口服500 mg阿莫西林后人体中的药代动力学参数。
