文档介绍：食品与药品 Food and Drug 2015年第17卷第3期 195
HPLC测定甲磺酸达比加群酯的含量
贾玲晓,唐磊,张淑婷,宋瑞芝,高占文
(山东鲁抗医药股份有限公司,山东济宁 272073)
摘要:目的建立高效液相色谱(HPLC)测定甲磺酸达比加群酯含量的方法。方法采用十八烷基键合硅胶色
谱柱( mm×250 mm,5 μm), mol/L甲酸铵-乙腈为流动相,梯度洗脱, mL/min;检测波
长315 nm。~ mg/mL,r=; %,RSD %(n=9)。结论本
方法简单、迅速、可靠,可用于甲磺酸达比加群酯的检测和质量控制。
关键词:甲磺酸达比加群酯;含量测定;高效液相色谱法
中图分类号:R917 文献标识码:A 文章编号:1672-979X(2015)03-0195-03
Determination of Dabigatran Etexilate Mesylate by HPLC
JIA Ling-xiao, TANG Lei, ZHANG Shu-ting, SONG Rui-zhi, GAO Zhan-wen
(Shandong Lukang Pharmaceutical co., Ltd., Jining 272073, China)
Abstract: Objective To establish an HPLC method for determination of dabigatran etexilate mesylate. Methods The
C18 column ( mm×250 mm, 5 μm) was gradient elution was adopted, with the mobile posed
of mol/L ammonium formate and acetonitrile. The flow rate was mL/min and the detective wavelength
was 315 The linear range of dabigatran etexilate mesylate was - mg/mL and the regression
coefficient was . The average recovery was %, with RSD of % (n=9).Conclusion The method was
simple, quick and reliable. It can be used for actual test and quality control of dabigatran etexilate mesylate.
Key Words:dabigatran etexilate mesylate; determination; HPLC
甲磺酸达比加群酯,系由德国勃林格殷格翰药的含量检测方法,为甲磺酸达比加群酯的质量控制
(Boehringer Ingelheim)公司研制开发,20