Determination of fexofenadine enantiomers in human plasma with high-performance liquid chromatography

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• 作者：Masatomo Miura ; Tsukasa Uno ; Tomonori Tateishi ; Toshio Suzuki
• 关键词：Fexofenadine ; Enantiomer ; HPLC ; Human plasma
• 刊名：Journal of Pharmaceutical and Biomedical Analysis
• 出版年：2007
• 期刊代码：65_07317085
• 类别：ch
• 出版时间：17 January 2007
• 卷：43
• 期：2
• 页码：741-745
• 文件大小：238 K

摘要

A simple and sensitive high-performance liquid chromatography (HPLC) method was developed as an assay for fexofenadine enantiomers in human plasma. Fexofenadine enantiomers were separated using a mobile phase of 0.5%KH₂PO₄–acetonitrile (65:35, v/v) on a Chiral CD-Ph column at a flow rate of 0.5 ml/min and measurement at 220 nm. Analysis required 400 μl of plasma and involved solid-phase extraction with an Oasis HLB cartridge, which gave recoveries for both enantiomers from 67.4 to 71.8%. The lower limit of quantification was 25 ng/ml for (R)- and (S)-fexofenadine. The linear range of this assay was between 25 and 625 ng/ml (regression line r² > 0.993). Inter- and intra-day coefficients of variation were less than 13.6%and accuracies were within 8.8%over the linear range for both analytes. This method can be applied effectively to measure fexofenadine enantiomer concentrations in clinical samples.