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
【期刊名称】《食品与药品》 【年(卷),期】2015(000)003
【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(4.6 mm×250 mm,5μm),以0.01 mol/L甲酸铵-乙腈为流动相,梯度洗脱,流速1.0 mL/min;检测波长315 nm。结果线性范围为0.098~1.17 mg/mL,r=0.9999;平均回收率98.96%,RSD 1.4%(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。%Objective To establish an HPLC method for determination of dabigatran etexilate mesylate.Methods The C18 column (4.6 mm×250 mm, 5μm) was used.The gradient elution was adopted, with the mobile phase composed of 0.01 mol/L ammonium formate and acetonitrile. The flow rate was 1.0 mL/min and the detective wavelength was 315 nm.Results The linear range of dabigatran etexilate mesylate was 0.098-1.17 mg/mL and the regression coefficient was 0.9999. The average recovery was 98.96 %, withRSD of 1.4 % (n=9).Conclusion The method was simple, quick and reliable. It can be used for actual test and quality control of dabigatran etexilate mesylate. 【总页数】3页(195-197)
【关键词】甲磺酸达比加群酯;含量测定;高效液相色谱法 【作者】贾玲晓;唐磊;张淑婷;宋瑞芝;高占文