RP-HPLC法测定人血浆中盐酸度洛西汀的浓度

目的：建立高效液相色谱法测定血浆中盐酸度洛西汀的浓度。方法：以盐酸普萘洛尔为内标，采用ZORBAX Eclipse XDB—C18色谱柱（150mm×4．6mm，5um）；流动相为5mmol·L^-1醋酸溶液（氨水调pH7．5）-甲醇-乙腈（33：30：37）；流速1ml·min^-1；荧光激发波长285nm，发射波长340nm；柱温40℃。结果：线性检测范围为1～100ng·ml^-1，r=0．9997。低、中、高3种浓度日内RSD分别为2．6％，1．8％，1．1％；日间RSD分别为3．9％，2．5％，2．0％；方法回收率分别为101．3％，99．6％，100．6％；萃取回收率分别为70．6％，72．4％，71．2％。结论：本法操作方便，结果准确，可用于盐酸度洛西汀的体内分析及临床药学研究。

Determination of Duloxetine Hydrochloride in Human Plasma by RP-HPLC

Objective： To establish an HPLC method to determine duloxetine hydrochloride in human plasma. Method： The propranolol hydrochloride Was used as an interal standard. Duloxetine hydrocb.loride and interal standard were separated on a ZORBAX Eclipse XDB-C18（150mm × 4.6mm,5um）column;The mobile phase was consisted of 5mmol·L^-1 acetic acid（ adjusted to pH7.5 with ammonia）-methanol-（ 33：30：37 ） at a flow rate of 1 ml·min^-1; A fluorescence detector was set at λex = 285nm, λem = 340nm and column temperature was controlled about 40℃. Result： A good linear range of duloxetine hydrochloride was 1 - 100 ng.ml^-1 ; the minimum detective concentration was 1 ng. ml^- 1, r = 0.999 7. Intra-day and inter-day RSD for assaying the plasma sample containing three concentration of duloxetine hydrochloride were 2.6% , 1.8% , 1.1% and 3.9%, 2.5 % ,2.0% （ n = 5 ） respectively; The relative recoveries of the three concentrations were 101.3% ,99.6%, 100.6% respectively. The extraction recoveries were 70.6% ,72.4% ,71.2% respectively. Conclusion： The method is simple and accurate, and it is can be applied to the clinical pharmaceutival research in vivo.