高效液相色谱法测定盐酸多奈哌齐片中的盐酸多奈哌齐  

Determination of donepezil hydrochloride in Donepezil Hydrochloride Tablets by HPLC

作　　者：陈泊颖 王博[2] 孟策[2] 陈欣怡[2] 任晓文[2] CHEN Bo-ying1 WANG Bo2 MENG Ce2 CHEN Xin-yi2 REN Xiao-wen2 1. Graduate School Tianjin University of Traditional Chinese Medicine Tianjin 300193 China 2. State Key Laboratory of Drug Delivery Technologies and Drug Metabolism Tianjin Institut of Pharmaceutical Research

机构地区：[1]天津中医药大学研究生院,天津300193 [2]天津药物研究院释药技术与药代动力学国家重点实验室,天津300193

出　　处：《药物评价研究》2016年第5期800-803,共4页Drug Evaluation Research

摘　　要：摘要：目的建立高效液相色谱法测定盐酸多奈哌齐片中盐酸多奈哌齐的方法。方法采用高效液相色谱法，用ThemoODSC18色谱柱（250mm×4．6mm，5μm）；以0．02mol／L庚烷磺酸钠-乙腈-高氯酸（50：50：1）为流动相；波长271m；柱温30℃；体积流量为1．0mL／mim进样体积20μL。结果盐酸多奈哌齐在50-350μg／mL与峰面积呈良好的线性关系，r=0．99．99（H=7）；平均加样回收率为99．34％，RSD值为0．72％（，z=9）。结论本法操作简便、准确，专属性强，重复性好，可用于盐酸多奈哌齐原料及盐酸多奈哌齐片的定量测定。Objective To develop an HPLC method for the content determination of donepezil hydroehloride in Donepezil Hydrochloride Tablets. Methods The HPLC analysis was performed on a Thermo ODS Cm8 column （250 mm× 4.6 mm, 5 μm）; 0.02 mol/L sodium 1-heptanesulfonate-acetonitrile-chlorine acid （50：50：1） was used as mobile phase; The detection wavelength was set at 271 nm and column temperature was maintained at 30℃; the flow rate was 1.0 mL/min and injection volume was 20 μL. Results The method showed a good linear relationship within the concentration range of 50 -- 350μg/mL （r = 0.999 9）, and the average recovery was 99.34% with RSD of 0.72% （n =9）. Conclusion This method is convenient, rapid, accurate, and with good specificity and reproducibility, which could be used for quantitative determination of donepezil raw material drug and Donepezil Hydrochloride Tablets.

关 键 词：高效液相色谱法 盐酸多奈哌齐 含量测定 

分 类 号：R917[医药卫生—药物分析学]