论文部分内容阅读
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 EclipseXDB-C_(18)色谱柱(150mm×4.6mm,5μm);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。
Objective: To establish a method for the determination of duloxetine hydrochloride in plasma by high performance liquid chromatography. METHODS: Propranolol hydrochloride was used as internal standard. The mobile phase consisted of 5 mmol·L -1 acetic acid (ammonia water, pH7.5 ) -methanol-acetonitrile (33:30:37); flow rate 1ml · min -1; fluorescence excitation wavelength 285nm, emission wavelength 340nm; column temperature 40 ℃. Results: The linear range of detection was 1 ~ 100 ng · ml ~ (-1), r = 0.9997. The intra-day RSD of low, medium and high concentrations were 2.6%, 1.8% and 1.1% respectively. The daytime RSD were 3.9%, 2.5% and 2.0%, respectively. The recoveries were 101.3%, 99.6% and 100.6% The recoveries were 70.6%, 72.4% and 71.2% respectively. Conclusion: This method is easy to operate with accurate results and can be used for in vivo analysis and clinical pharmacy study of duloxetine hydrochloride.