Determination concentration of duloxetine hydrochloride in human plasma by HPLC-MS/MS and study on its pharmacokinetics
10.3969/j.issn.1001-6821.2010.02.015
- VernacularTitle:液相色谱-串联质谱法测定人血浆中盐酸度洛西汀的浓度及其药代动力学研究
- Author:
Rui-Ke ZHAO
1
;
Jia-Wen LIU
;
Gang CHENG
;
Jing TANG
;
Juan SONG
;
Wen-Xing PENG
Author Information
1. 中南大学,湘雅二医院
- Keywords:
duloxetine;
LC-MS/MS;
plasma concentration
- From:
The Chinese Journal of Clinical Pharmacology
2010;26(2):137-140
- CountryChina
- Language:Chinese
-
Abstract:
Objective To establish a liquid chromatography-tandem mass spectrometry(LC-MS/MS)method for the determination concentration of duloxetine in human plasma and study on its pharmacokinetics in healthy human.Methods The separation of duloxetine was performed on Phenomenex C_(18) column with fluoxetine as the internal standard.The mobile phase was composed of 5 mmol L~(-1) ammonium acetate with 0.02% formic acid acetonitrile(55:45).Electrospray ionization source was applied and operated in positive ion mode.A single dose of 60 mg duloxetine hydrochloride was given to 5 male and 5 female healthy volunteers and the plasma was separated.The concentration of duloxetine was determined by HPLC-MS/MS and the pharmacokinetic parameters were calculated.Results The linear range of duloxetine was 0.89-106.80 ng·mL~(-1)(γ=0.9977).The methodological recovery and the extraction recovery ranged between 93.19%-107.27% and 72.81%-89.96%,respectively.Both the inter-day RSD and intra-day RSD were less than 11%.The main pharmacokinetic parameters after a single dose of 60mg duloxetine are as follows: C_(max) was(44.40 ±17.78)ng·mL~(-1),t_(max) was(6.10±1.29)h,t_(1/2) was(12.81 ±2.31)h;AUC_(0-60) and AUC_(0-∞) were (696.04±337.82),(733.82±343.40)ng·h·mL~(-1),respectively.Conclusion The method is simple,accurate and reliable,and suitable for the determination of duloxe-tine in therapeutic drug monitor and its pharmacokinetics study.
