Metz R, Muth P, Ferger M, Kukes V G, Vergin H
Heumann Pharma, Nürnberg, Germany.
J Chromatogr A. 1998 Jun 12;810(1-2):63-9. doi: 10.1016/s0021-9673(97)01006-6.
A highly sensitive and selective HPLC method was developed and validated for the determination of arbidol in human plasma. The method involves the liquid-liquid extraction of drug and internal standard from plasma with tert.-butyl methyl ether followed by evaporation and reconstitution in mobile phase. UV detection was done at 315 nm. The limit of quantification for arbidol in plasma was 0.005 microgram/ml. Linearity in plasma was proven over the whole calibration range (10.2-0.005 micrograms/ml). The method was validated according to GLP guidelines and its suitability was demonstrated by analysis of samples from a pharmacokinetic study.
建立了一种高灵敏度和高选择性的HPLC方法并进行了验证,用于测定人血浆中的阿比朵尔。该方法包括用叔丁基甲醚从血浆中液-液萃取药物和内标,然后蒸发并在流动相中重新溶解。在315nm处进行紫外检测。血浆中阿比朵尔的定量限为0.005微克/毫升。在整个校准范围内(10.2 - 0.005微克/毫升)证明了血浆中的线性关系。该方法根据GLP指南进行了验证,通过对药代动力学研究的样品分析证明了其适用性。