Miura Masatomo, Uno Tsukasa, Tateishi Tomonori, Suzuki Toshio
Department of Pharmacy, Akita University Hospital, 1-1-1 Hondo, Akita 010-8543, Japan.
J Pharm Biomed Anal. 2007 Jan 17;43(2):741-5. doi: 10.1016/j.jpba.2006.07.033. Epub 2006 Aug 24.
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% KH(2)PO(4)-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 microl 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 r(2)>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.
建立了一种简单、灵敏的高效液相色谱（HPLC）法，用于测定人血浆中非索非那定对映体。在Chiral CD-Ph柱上，以0.5%KH(2)PO(4)-乙腈（65:35，v/v）为流动相，流速为0.5 ml/min，于220 nm处进行检测，分离非索非那定对映体。分析需要400 μl血浆，采用Oasis HLB柱进行固相萃取，两种对映体的回收率为67.4%至71.8%。（R）-和（S）-非索非那定的定量下限均为25 ng/ml。该测定方法的线性范围为25至625 ng/ml（回归线r(2)>0.993）。两种分析物在日内和日间的变异系数均小于13.6%，在整个线性范围内的准确度均在8.8%以内。该方法可有效应用于临床样本中非索非那定对映体浓度的测定。
