Pruñonosa J, Parera L, Peraire C, Pla F, Lavergne O, Obach R
Pharmacokinetic Department, S.A. Lasa Laboratorios, Sant Felíu de Llobregat, Barcelona, Spain.
J Chromatogr B Biomed Appl. 1995 Jun 23;668(2):281-90. doi: 10.1016/0378-4347(95)00085-w.
A sensitive and selective HPLC-solid-phase extraction procedure was developed for the determination of platelet-activating factor antagonist BN-50727 and its metabolites in human plasma. The procedure consisted of an automated solid-phase extraction of the drug and metabolites on disposable propylcarboxylic acid cartridges, followed by on-line chromatographic separation. The method was linear from 3.75 to 2400 ng/ml and the limit of quantitation for BN-50727 in plasma samples was 3.75 ng/ml. The within-run precision of the method, expressed as relative standard deviation, ranged from 2.1 to 8.1%. The accuracy, expressed as relative error, ranged from -3.5 to 4.0%. For the main metabolite, the O-demethylated BN-50727 product, the method was linear from 7.5 to 2400 ng/ml and the limit of quantitation in plasma was 7.5 ng/ml. The within-run precision ranged from 2.1 to 11.0% and the accuracy from -5.3 to 1.1%. This paper describes the validation of the analytical methodology for the determination of BN-50727 in human plasma and also of its metabolites. The method has been used to follow the time course of BN-50727 and its metabolites in human plasma after administration of single and multiple doses.
建立了一种灵敏且具选择性的高效液相色谱-固相萃取法，用于测定人血浆中血小板活化因子拮抗剂BN-50727及其代谢产物。该方法包括在一次性丙基羧酸柱上对药物及其代谢产物进行自动固相萃取，随后进行在线色谱分离。该方法在3.75至2400 ng/ml范围内呈线性，血浆样品中BN-50727的定量限为3.75 ng/ml。该方法的批内精密度以相对标准偏差表示，范围为2.1%至8.1%。准确度以相对误差表示，范围为-3.5%至4.0%。对于主要代谢产物O-去甲基化的BN-50727产物，该方法在7.5至2400 ng/ml范围内呈线性，血浆中的定量限为7.5 ng/ml。批内精密度范围为2.1%至11.0%，准确度范围为-5.3%至1.1%。本文描述了测定人血浆中BN-50727及其代谢产物的分析方法的验证情况。该方法已用于跟踪单次和多次给药后人血浆中BN-50727及其代谢产物的时间进程。
