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目的:建立人血浆中特非那定的高效液相色谱一电喷雾质谱联用(HPLC/ESI-MS)测定方法.方法:以氟桂利嗪为内标,血浆以2 mol/L NaOH溶液碱化后,经乙酸乙酯提取;选用Phenomenex C18色谱柱(250 mm×4.6 mm,5μm),柱温25℃;流动相为甲醇-水80:20(含1%的冰醋酸和0.5%的三乙胺),流速1 mL/min;采用四级杆电喷雾质谱检测器进行定量,选择性正离子检测(SIM),特非那定m/z 472,氟桂利嗪m/z 203.结果:本法线性范围为0.1～20 ng/mL,最低检测限为0.05 ng/mL(S/N＞3),血浆中特非那定的日内和日间精密度为2.54%～9.28%,回收率为88.62%～91.67%.结论:本法专属性强、灵敏度高,适用于临床试验中特非那定的药代动力学研究.“,”AIM: To establish a highly sensitive method for the quantitation of terfenadine in human plasma by using high performance liquid chromatogram-electrospray ionization-mass spectrometry (LC-ESI-MS). METHODS: Flunarizine was chosen as the internal standard .(I. S.), the plasma was extracted by ethyl acetate after alkalized with 2 mol/L sodium hydroxide, and the Phenomenex C_(18) chromatographic eolumn(250 mm × 4.6 mm, 5 μm)was used, the column temperature was 25 ℃, the mobile phase was methanol-water (80:20) including 1 % glacial acetic acid and 0.5% triethylamine. The flow rate was 1 mL/ min. Analytes were quantitated using positive electros-pray ionization in a quadrupole spectrometer. The selected ion monitoring(SIM) mode was detected, terfenadine ml z was 472 and flunarizine mlz was 203. RESULTS: The linear range was 0.1 - 20 ng/mL, the lowest detectable limit was 0.05 ng/mL (S/N > 3), The intra and inter-assay precision of terfenadine was 2.54% - 9.28% . The recovery of terfenadine in plasma was 88.62% - 91.67%. CONCLUSION: The method has strong specificity and high sensitivity and can be used for clinical experiment of terfenadine phar-macokinetic study.