高效液相色谱法测定甲磺酸达比加群酯胶囊的含量  

Determination of Dabigatran Etexilate Mesylate Capsules by HPLC

作　　者：杨晓枫 郭彬露 周懿峰 汤欣 季媛媛 陈纭[1,2] YANG Xiao-feng;GUO Bin-lu;ZHOU Yi-feng;TANG Xin;JI Yuan-yuan;CHEN Yun(School of Pharmacy,Anhui Medical University,Hefei 230032,China;Inflammation and Immune Mediated Disease Laboratory of Anhui Province,Anhui Medical University,Hefei 230032,China)

机构地区：[1]安徽医科大学药学院,安徽合肥230032 [2]安徽医科大学炎症免疫性疾病安徽省实验室,安徽合肥230032

出　　处：《海峡药学》2023年第3期13-17,共5页Strait Pharmaceutical Journal

基　　金：安徽医科大学药学院本科生“早期接触科研”训练计划立项项目(1908085QH350);安徽医科大学药学创新基金科研项目(编号:YXCX202201)。

摘　　要：目的建立一种简便、灵敏的测定方法来检测甲磺酸达比加群酯胶囊的含量。方法采用高效液相色谱法测定甲磺酸达比加群酯胶囊中主药的含量,色谱柱:ODS C_(18)(250 mm×4.6 mm,5μm),流动相∶甲醇-水(75∶25,水中加0.1%三乙胺),检测波长:323 nm,流速:1.0 mL·min^(-1);柱温:35℃;进样体积:10μL。结果甲磺酸达比加群酯在0.5~10μg·mL^(-1)范围内线性关系良好(R^(2)=0.9999),平均回收率为98.93%,RSD为0.46%。结论该方法操作便捷、灵敏度高,结果准确,可用于甲磺酸达比加群酯胶囊中甲磺酸达比加群酯的含量测定。OBJECTIVE To establish a simple,sensitive determination of dabigatran etexilate mesylate capsules.METHODS HPLC method was adopted.The separation was performed on a ODS C_(18)(250 mm×4.6 mm,5μm),column with mobile phase consisted of methanol-water(75∶25,0.1%triethylamine in water)and the detection wavelength was 323 nm.The flow rate was 1.0 mL·min^(-1).The column temperature was 35℃.The injection volume was 10μL.RESULTS The linear range of dabigatran etexilate mesylate was 0.5-10μg·mL^(-1)(R^(2)=0.9999).The average recovery was 98.93%(RSD=0.46%,n=9).CONCLUSION The method is simple and accurate,which can be used in the quantitative determination of dabigatran etexilate mesylate in capsules.

关 键 词：甲磺酸达比加群酯胶囊 高效液相色谱法 含量测定 

分 类 号：R927[医药卫生—药学]