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目的采用HPLC测定人血浆中尼麦角林主要代谢物10α-甲氧基-6-甲基麦角林-8β-甲醇(MDL)的血药浓度。方法色谱柱为Luna C18柱(250 mm×4.6 mm,10μm),流动相为乙腈-0.01 mol.L-1磷酸氢二钠(15:85,磷酸调pH3.5),流速为1.0 ml.min-1,柱温30℃,检测波长为225 nm。结果线性范围为5.0~80.0 ng.ml-1(r=0.9997,n=7),平均方法回收率分别为93.85%、94.83%、89.84%;日内RSD分别为4.93%、8.23%、10.63%(n=5),日间RSD分别为6.17%、6.13%、8.41%(n=5)。结论该法灵敏、简便、准确,适用于尼麦角林及相关制剂的临床研究。
Objective To determine the plasma concentration of 10α-methoxy-6-methylergoline-8β-methanol (MDL), a major metabolite of nicergoline in human plasma, by HPLC. Methods The column was a Luna C18 column (250 mm × 4.6 mm, 10 μm). The mobile phase was acetonitrile-0.01 mol·L -1 disodium hydrogen phosphate (15:85, phosphoric acid, pH 3.5) at a flow rate of 1.0 ml · min -1, column temperature 30 ℃, detection wavelength of 225 nm. The linear range was 5.0-80.0 ng.ml-1 (r = 0.9997, n = 7). The average recovery rates were 93.85%, 94.83% and 89.84%, respectively. The intra-day RSD were 4.93%, 8.23% and 10.63% n = 5). The daytime RSDs were 6.17%, 6.13% and 8.41%, respectively (n = 5). Conclusion The method is sensitive, simple and accurate and is suitable for the clinical research of nicergoline and related preparations.