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目的：建立测定人血浆中芬太尼（Ｆｅｎ）浓度的ＨＰＬＣ测定法，为临床Ｆｅｎ的药动学研究提供科学的分析技术。方法：Ｆｅｎ测定以μＢｏｎｄａｐａｋＣ１８为固定相，水（含０．００５ｍｏｌ·Ｌ－１辛烷磺酸钠和０．０１ｍｏｌ·Ｌ－１磷酸）乙腈（６９∶３１）为流动相，以阿芬太尼为内标物，紫外检测波长为２２０ｎｍ。结果：验证实验表明，Ｆｅｎ与内标物分离良好，血浆中Ｆｅｎ的平均回收率为９９．９７％，日内、日间的ＲＳＤ值均小于８％。血药浓度在１０ｎｇ·ｍｌ－１～２００ｎｇ·ｍｌ－１范围内与峰面积呈线性关系，ｒ＝０．９９９６。本方法最低检测浓度为５ｎｇ·ｍｌ－１。结论：本方法具有较高的准确度，方法灵敏，专一性好，适用于临床Ｆｅｎ血药浓度的测定。
OBJECTIVE: To establish an HPLC method for the determination of Fen concentration in human plasma, and to provide a scientific analytical technique for the pharmacokinetics study of clinical Fen. Methods: The determination of Fen was performed with μBondapakC18 as stationary phase, water (containing 0.005mol·L-1 sodium octane sulfonate and 0.01mol·L-1 phosphate )acetonitrile (69:31) as mobile phase, To alfentanil as internal standard, UV detection wavelength of 220nm. Results: Validation experiments showed that Fen and internal standard were well separated. The average recovery rate of Fen in plasma was 99.97%. The daily and intraday RSD values were less than 8%. Plasma concentration in the range of 10ng · ml-1 ~ 200ng · ml-1 and the peak area was linear, r = 0.9996. The minimum detection concentration of this method is 5ng · ml-1. Conclusion: The method has high accuracy, sensitive and specific, and is suitable for the determination of clinical serum concentration of Fen.