de Jager A D, Hundt H K L, Swart K J, Hundt A F, Els J
FARMOVS-PAREXEL-Bioanalytical Serviced Division, Private Bag X09, Brandhof 9324, Bloemfontein, South Africa.
J Chromatogr B Analyt Technol Biomed Life Sci. 2002 Jun 25;773(2):113-8. doi: 10.1016/s1570-0232(02)00134-4.
Following a single 10-mg oral dose of cetirizine dihydrochloride to 24 healthy volunteers, the analyte was quantified in human plasma. Protein precipitation using acetonitrile (ACN) was followed by reversed-phase liquid chromatography and tandem mass spectrometry. The MS/MS method was optimised using a PE Sciex API 2000 triple quadrupole mass spectrometer in selected reaction monitoring (SRM) mode, using electrospray with positive ionisation. Oxybutynin was used as the internal standard. The assay method represents a robust, high-throughput, highly specific and sensitive quantitative assay procedure, with 0.5 ng/ml being the lowest plasma concentration that could be reliably quantified. The procedure involves minimal sample preparation, and is well suited to clinical studies of the drug involving large numbers of generated samples. Pre-dose as well as post-dose samples up to and including 48 h were quantified, and the data generated were used to determine the pharmacokinetic profile of the drug.
给24名健康志愿者口服单次10毫克的盐酸西替利嗪后，对人血浆中的分析物进行了定量分析。使用乙腈（ACN）进行蛋白沉淀，随后进行反相液相色谱和串联质谱分析。采用PE Sciex API 2000三重四极杆质谱仪在选择反应监测（SRM）模式下，以正离子电喷雾电离对MS/MS方法进行了优化。奥昔布宁用作内标。该测定方法是一种稳健、高通量、高特异性和高灵敏度的定量测定方法，0.5纳克/毫升是能够可靠定量的最低血浆浓度。该方法所需的样品制备最少，非常适合涉及大量样本的该药物的临床研究。对给药前以及给药后直至48小时的样本进行了定量分析，并利用所生成的数据确定了该药物的药代动力学特征。
