HPLC-MS测定人血浆中美利曲辛及其在生物等效性研究中的应用  

Determination of melitracen in human plasma by HPLC-MS and its bioequivalence

作　　者：王凯[1] 张毕奎[2] 陈本美[3] 朱运贵[4] 谢悦良[2] 

机构地区：[1]湖南省人民医院药剂科,长沙410005 [2]中南大学湘雅三医院药剂科,长沙410013 [3]中南大学现代分析测试中心生物分析化学教研室,长沙410009 [4]中南大学湘雅二医院药剂科,长沙410011

出　　处：《中南药学》2012年第8期601-604,共4页Central South Pharmacy

摘　　要：目的建立测定人血浆中美利曲辛浓度的高效液相色谱-质谱联用法,并用于氟哌噻吨美利曲辛片的生物等效性研究。方法血浆样品用乙酸乙酯萃取,采用Thermo Hypersil-HyPURITY C18色谱柱(150mm×2.1mm,5μm)分离,以50mmol·L-1乙酸铵溶液(pH=4.0)-甲醇-乙腈(45∶36∶19)为流动相,流速为0.22 mL·min-1。采用高效液相色谱-质谱电喷雾电离法,选择离子监测(SIM)。结果美利曲辛在0.4～50.0μg·L-1线性关系良好,平均回收率为98.6%,日内RSD≤7.8%,日间RSD≤6.0%。结论该方法准确、灵敏度高,适用于含美利曲辛制剂的人体药动学和生物等效性研究。Objective To develop a high performance liquid chromatography-mass spectrometry（HPLC-MS） method for the determination of melitracen in human plasma and study its bioequivalence.Methods Melitracen concentration in the plasma was determined by HPLC-MS.Melitracen were extracted from the plasma by liquid-liquid extraction,and the separation was performed on a Thermo Hypersil-HyPURITY C18 column,using the mobile phase consisting of 50 mmol·L-1 ammonium acetate（pH=4.0）-methanol-acetonitrile（45∶36∶19） with a flow rate of 0.22 mL·min-1.The compounds were ionized in the electrospray ionization（ESI） ion source of the mass spectrometer and detected in the selected ion recording（SIR）mode.Results The calibration curve was linear at 0.4-50.0 μg·L-1（r=0.999 3）,the average recovery was 98.6%,the RSDs of intra-and inter-day were less than 7.8% and 6.0%.Conclusion The method is accurate and sensitive for the determination of melitracen in human plasma.

关 键 词：美利曲辛 高效液相色谱-质谱 生物等效性 

分 类 号：R969.1[医药卫生—药理学]