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首页> 外文期刊>Journal of Pharmaceutical Analysis >Determination of metabolite of nicergoline in human plasma by high-performance liquid chromatography and its application in pharmacokinetic studies
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Determination of metabolite of nicergoline in human plasma by high-performance liquid chromatography and its application in pharmacokinetic studies

机译：高效液相色谱法测定人血浆中麦角灵的代谢物及其在药代动力学研究中的应用

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摘要

A fast, simple and sensitive high performance liquid chromatographic (HPLC) method has been developed for determination of 10 α -methoxy-6-methyl ergoline-8 β -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 (150mm×4.6mm, 5μm) using acetonitrile–ammonium acetate (0.1mol/L) (15/85, v/v) as mobile phase at detection wavelength of 224nm. The calibration curves were linear over the range of 2.288–73.2ng/mL with a lower limit of quantitation (LLOQ) of 2.288ng/mL. The intra- and inter-day precision values were below 13% and the recoveries were from 74.47% to 83.20% at three quality control levels. The method herein described was successfully applied in a randomized crossover bioequivalence study of two different nicergoline preparations after administration of 30mg in 20 healthy volunteers.
机译：开发了一种快速，简单，灵敏的高效液相色谱（HPLC）方法，用于测定人血浆中的10α-甲氧基-6-甲基麦角灵8β-甲醇（MDL，尼麦角林的主要代谢物）。采用二步法进行的液-液萃取（LLE）进行样品制备。选择盐酸替扎尼定作为内标（IS）。在Diamonsil ODS色谱柱（150mm×4.6mm，5μm）上进行分析，使用乙腈-乙酸铵（0.1mol / L）（15/85，v / v）作为流动相，检测波长为224nm。校正曲线在2.288-73.2ng / mL范围内呈线性，定量下限（LLOQ）为2.288ng / mL。在三个质量控制水平上，日内和日间精度值低于13％，回收率从74.47％至83.20％。在20位健康志愿者中服用30 mg后，本文所述方法已成功应用于两种不同麦角戈林制剂的随机交叉生物等效性研究。

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