| abstract |
The present invention relates to a kind of detection method of dabigatran etexilate mesylate, described method steps are as follows: prepare need testing solution, reference substance solution, then inject high performance liquid chromatograph respectively and detect, wherein, need testing solution The preparation adopts that the sample is dissolved with acetonitrile-water (1:1) and filtered with a microporous membrane. The chromatographic conditions include using octadecylsilane bonded silica gel as a filler, and the mobile phase is 0.02mol/L acetic acid Ammonium (adjust PH8.0 with triethylamine)-acetonitrile (35:65), the chromatographic column is 4.6mm * 250mm, the Phenomenex Gemini C18 chromatographic column of 5 μm, detection wavelength 220nm, the peak shape of each component that the inventive method analysis obtains Good, good separation, simple operation, high precision, high recovery, good stability and repeatability. |