液相色谱—电喷雾质谱法测定人血浆中非那雄胺的浓度

Determination of the Concentration of Finasteride in Human Plasma With LC-MS

目的：建立液相色谱—电喷雾质谱法测定人口服非那雄胺药物后的血药浓度。方法：液相：采用Hypurlty C18柱（Thermo Hypersil—Keystone 2．1’150mm，5μ US）色谱柱，柱温：40°；流动相：乙腈：水=45：54（含0．1％乙酸：0．1％TFA）。质谱：电喷雾离子源（ESI），选择离子监测（SIR）质荷比M／Z=373（非那雄胺）；237（内标），血样用乙腈直接沉淀。结果：在1～64ng／ml范围内与非那雄胺和内标的峰面积比值之间线性关系良好（r=0．999），最低检测浓度0．5ng／ml；日内及日间差异分别低于15％和20％；1、16、64ng／ml的相对平均回收率分别为114％、100％和99％。结论：此方法灵敏、准确，适用于药物动力学和药效学研究。

Objective： the LC - MS method was established to determine the concentration of drug in blood after taking the finasteridc orally. Method： Liquid phase： Hypurity C18 （Thermo Hypersil - Keystone 2. 1＇150mm , 5μUS）, temperature： 40℃ ; mobile phase ： acetonitfile： water = 45 ： 54 （0.1% acetic acid： 0. 1% TFA）. Mass spectra： ESI, M/Z = 373 （finasteride） ;237 （ internal standard）, blood sample was directly precipitate with acetonitrile. Result： at the range of 1～64ng/ml, the peak area ratio between finastefide and internal standard showed a good linearity（ r =0. 999）, the lowest detecting concentration was 0.5ng/rul; the difference was lower than 15% and 20% on one day and daytime; the relative average recovery were respectively 114%, 100% and 99% with relative concentration 1,16,64ng/rul. Conclusion： the method is sensitive and accurate, fit for the research of pharmacokinetics and pharmacodynamies.