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本研究建立了高敏感度、具选择性且快速的LC-MS/MS测定方法,用以定量测定人血浆中非索非那定的浓度。含非索非那定血浆样品在用乙腈沉淀蛋白质处理后,经Eclipse XDB-C8层析管柱分离,流动相为1 mmol/L醋酸铵缓冲盐溶液(包含0.2%甲酸)–甲醇(45:55,v/v),以电喷雾串联质谱法定量。流动相流速设定在1 mL/min,并选用氯沙坦为内标,非索非那定与内标的保留时间分别为1.76 min与2.65 min。线性范围是1–1000 ng/mL,方法的批内和批间相对标准偏差精密度分别小于10.4%和15.4%。此液相色谱串联质谱仪法相较于过去已发表的分析方法,提供了更灵敏的定量能力。分析方法亦已成功应用于非索非那定在台湾健康受试者体内的药代动力学研究。
This study established a high sensitive, selective and rapid LC-MS / MS method for the quantitative determination of fexofenadine in human plasma. Samples of fexofenadine-containing plasma were separated on an Eclipse XDB-C8 chromatographic column after the protein was precipitated with acetonitrile and the mobile phase consisted of 1 mmol / L ammonium acetate buffered saline solution (containing 0.2% formic acid) -methanol (45: 55, v / v), quantified by electrospray tandem mass spectrometry. The mobile phase flow rate was set at 1 mL / min and losartan was selected as internal standard. The retention times of fexofenadine and internal standard were 1.76 min and 2.65 min, respectively. The linearity range was 1-1000 ng / mL. The relative standard deviation precision of the method was less than 10.4% and 15.4%, respectively. This LC tandem mass spectrometry method provides more sensitive quantification capabilities than previously published analytical methods. Analytical methods have also been successfully applied to the pharmacokinetics of fexofenadine in healthy volunteers in Taiwan.