高效液相色谱法检测甲磺酸达比加群酯及有关物质

为了研究甲磺酸达比加群酯的有关物质，本研究合成了7个有关化合物，建立了相关的HPLC检测方法(以XBridge C₁₈为色谱柱，甲醇-0.01 mol/L磷酸二氢钾为流动相梯度洗脱，检测波长为310 nm)，并对样品的溶解溶剂和进样体积进行了筛选。结果显示，所建立的HPLC分析方法能使达比加群酯和7个化合物达到完全分离，且重复性好，准确度高，适用于甲磺酸达比加群酯有关物质的检测。

Determination of dabigatran etexilate mesylate and related substances by HPLC

In order to research the related substances of dabigatran etexilate mesylate, seven related compounds were synthesized and the related detection methods were established(Using XBridge C₁₈ as the column, methanol-0. 01mol/L potassium dihydrogen phosphate as the mobile phase Gradient elution, detection wavelength of 310 nm). The solvents and the injection volume were also screened. Results showed that the established method could separate the dabigatran etexilate mesylate and seven compounds completely, and the reproducibility was good and the accuracy was high, which was suitable for the detection of the related substances of dabigatran etexilate mesylate.