建立HPLC-ESI-SIM法测定盐酸多奈哌齐在血浆中的含量  

To establish an HPLC-ESI-SIM method for the determination of donepezil in human plasma

作　　者：李艳翠[1] 辛华[1] 高丽[2] 

机构地区：[1]黑龙江省佳木斯大学附属第一医院,黑龙江佳木斯154003 [2]北京科信必成医药科技发展有限公司哈尔滨分公司,黑龙江哈尔滨154000

出　　处：《中国美容医学》2012年第11X期24-26,共3页Chinese Journal of Aesthetic Medicine

摘　　要：目的:研究盐酸多奈哌齐口服制剂在健康人体的药动学特征及生物等效性,建立HPLC-ESI-SIM方法测定血浆中的盐酸多奈哌齐浓度。方法:以乙哌立松为内标,待测血浆经碱化处理后,经乙酸乙酯进行液-液萃取,采用ODS-2C18柱(250mm×2.0mm,5μm),以甲醇-20mmol/L醋酸溶液(60:40)为流动相,流速0.8mL/mi n,柱温35℃。采用质谱电喷雾离子源正源(ESI+)将样品离子化,选择性离子监测(SIM)准分子离子峰。结果:多奈哌齐在0.10～20.0ng/mL内线性关系良好(r=0.9997),最低定量限为0.1ng/mL。方法回收率为92.9%～98.4%,提取回收率均大于80%,批内与批间RSD均小于10%。结论:该方法简单、快速、灵敏度高、专属性强,适用于人血浆中多奈哌齐浓度的测定及药动学研究。Objective To study the pharmacokinetics and bioavailability of Donepezil Hydrochloride in healthy volunteers. To establish an HPLC-ESI-SIM method for the determination of donepezil in human plasma. Methods Alkalized plasma was extracted with ethyl acetate and Eperisone was used as internal standard.Solutes were separated on a ODS-2C18 column （250mm×2.0mm,5 μm）with a mobile phase of methanol-20mmol/L Acetic acid solution （60：40）,The flow rate was 0.8mL/min and column was used with temperature of 35℃.Donepezil and internal standard were ionized in the eletrospray ionization （ESI＋） with positive source of the mass spectrometer and detected in selected ionization monitor （SIM） mode. Results The calibration curve was linear in the range of 0.1-20.Ong/mL （r= 0.9997） with the lower limit of quantitation, accuracy was within 92.9%～98.4% The recovery of the extraction was more than 80%, intra- and inter-batch precision （RSD） were less than 10%. Conclusion The method is proved to be suitable for pharmacokinetics and determination of donepezil in human plasma with simple,quickness,sensitive and specificity.

关 键 词：多奈哌齐 HPLC-ESI-SIM 血药浓度 

分 类 号：R927[医药卫生—药学]