高效液相色谱法测定芬太尼的血药浓度

目的：建立测定人血浆中芬太尼浓度的高效液相色谱法。方法：本实验采用外标法，以正己烷-乙醇（20：1）为提取溶剂；采用HypersilODS-C18（4．6mmX250mm，5Ixm）色谱柱，溶剂A（甲醇：乙腈：冰醋酸=400：200：0．6）-溶剂B0．2％无水硫酸钠的醋酸铵溶液（1．5—100）]=68：32为流动相（pH=6．5），流速为1．0mL·min-1，柱温为室温，检测波长为220nm。结果：芬太尼的血浆浓度在0．476～19．048μg·L-1范围内线性关系良好（r=0．9999），最低定量限为0．476μg·L-1，方法回收率为100．0％～114．7％，萃取回收率97．3％～98．6％，日内、日间精密度均小于2％。结论：本方法操作简便、准确度和灵敏度高，适用于临床芬太尼微量血药浓度检测及药动学的研究。

Determination of Fentanyl in Human Plasma by HPLC

OBJECTIVE： To determine the concentration of fentanyl in human plasma by HPLC. METHODS： The HPLC determination was performed by external standard method. The chromatographic separation was carried out on Hypersil ODS-C18 （4.6 mm ×250 mm, 5μm） column. The mobile phase consisted of solvent A （methanol： acetonitrile： glacial acetic acid = 400： 200： 0. 6） and solvent B （1.5% acetate solution containing 0. 2% anhydrous sodium sulfate） with the ratio of A： B =68：32 （pH=6. 5）. The flow rate was 1.0 mL·in-1 ; the column temperature was set at room temperature and the UV detection wavelength was set at 220 nm. RESULTS： The calibration curve for fentanyl was linear in the range of 0. 476 -19. 048μg·L-1 （r =0. 999 9）. The lowest quantification limit was 0. 476μg·L-1; the methodological recovery was 100. 0% - 114. 7% and the extraction recovery was 97.3% -98.6%. Both the intra-day and inter-day RSDs were less than 2%. CONCLUSION： The method was proved to be simple, accurate and sensitive, and it is applicable for determination of the trace concentration of fentanyl in human plasma and its pharmacokinetic study.