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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
【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.
【Key words】 Dabigatran etexilate mesylate capsules; Determination; HPLC;
- 【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