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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

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【作者】 杨晓枫郭彬露周懿峰汤欣季媛媛陈纭

【Author】 YANG Xiao-feng;GUO Bin-lu;ZHOU Yi-feng;TANG Xin;JI Yuan-yuan;CHEN Yun;School of Pharmacy, Anhui Medical University;Inflammation and Immune Mediated Disease Laboratory of Anhui Province, Anhui Medical University;

【通讯作者】 陈纭;

【机构】 安徽医科大学药学院安徽医科大学炎症免疫性疾病安徽省实验室

【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 C18(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(R2=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。

【Abstract】 OBJECTIVE To establish a simple, sensitive determination of dabigatran etexilate mesylate capsules.METHODS HPLC method was adopted.The separation was performed on a ODS C18(250 mm×4.6 mm, 5 μm),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 10 μL.RESULTS The linear range of dabigatran etexilate mesylate was 0.5-10 μg·mL-1(R2=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.

【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)
  • 【文献出处】 海峡药学 ,Strait Pharmaceutical Journal , 编辑部邮箱 ,2023年03期
  • 【分类号】O657.72;R927.2
  • 【下载频次】30
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