Vink J, van Hal J H, Pognat J F, Bouquet des Chaut J L
J Chromatogr. 1983 Jan 14;272(1):87-94. doi: 10.1016/s0378-4347(00)86105-8.
An assay has been developed to determine the anti-ischaemic drug bepridil (as its free base) in human plasma. The assay procedure comprises n-hexane extraction from basic plasma and gas chromatography using nitrogen-selective detection. An analogue of bepridil is used as internal standard. The accuracy and precision of the assay is determined by repeated analyses of drug-free plasma samples spiked with 5, 10, 20, 100, 400 and 1000 ng of bepridil per ml of plasma. The accuracy, defined as the relative difference between the mean bepridil concentration found and the true value, was 8% or better. The precision (relative standard deviation) was 13% at the 5 ng/ml level and 5% at the 1000 ng/ml level. The assay is suitable to monitor routinely bepridil plasma levels during clinical studies.
已开发出一种用于测定人血浆中抗缺血药物苄普地尔(以其游离碱形式)的分析方法。该分析方法包括从碱性血浆中用正己烷萃取以及使用氮选择性检测的气相色谱法。苄普地尔的一种类似物用作内标。通过对每毫升血浆中加入5、10、20、100、400和1000纳克苄普地尔的无药物血浆样品进行重复分析来确定该分析方法的准确性和精密度。准确性定义为所测得的苄普地尔平均浓度与真实值之间的相对差异,为8%或更好。精密度(相对标准偏差)在5纳克/毫升水平时为13%,在1000纳克/毫升水平时为5%。该分析方法适用于在临床研究期间常规监测苄普地尔的血浆水平。