Determination of metabolite of nicergoline in human plasma by high-performance liquid chromatography and its application in pharmacokinetic studies
10.1016/j.jpha.2011.09.005
- Author:
Rong ZHENG
;
Yihong WU
;
Dexi JIANG
;
Dan ZHANG
- Publication Type:Journal Article
- Keywords:
Nicergoline;
10α-methoxy-6-methylergoline-8β-methanol (MDL);
HPLC;
Plasma-drug concentration;
Bioequivalence study
- From:
Journal of Pharmaceutical Analysis
2012;02(1):62-66
- CountryChina
- Language:Chinese
-
Abstract:
A fast,simple and sensitive high performance liquid chromatographic (HPLC) method has been developed for determination of 10α-methoxy-6-methyl ergoline-8β-methanol (MDL,a main metabolite of nicergoline) in human plasma.One-step liquid-liquid extraction (LLE) with diethyl ether was employed as the sample preparation method.Tizanidine hydrochloride was selected as the internal standard (IS).Analysis was carried out on a Diamonsil ODS column (150 mm × 4.6 mm,5 μm) using acetonitrile-ammonium acetate (0.1 mol/L) (15/85,v/v) as mobile phase at detection wavelength of 224 nm.The calibration curves were linear over the range of 2.288-73.2 ng/mL with a lower limit of quantitation (LLOQ) of 2.288 ng/mL.The intra- and inter-day precision values were below 13％ and the recoveries were from 74.47％ to 83.20％ at three qtality control levels.The method herein described was successfully applied in a randomized crossover bioequivalence study of two different nicergoline preparations after administration of 30 mg in 20 healthy volunteers.
