Objective: To establish a HPLC method for determination of the content and related substance of calcium dobesilate. Method: The separation was performed on a Kromasil C8 column (4.6 mm×200 mm

5 μm). The mobile phase was composed of 50 mmol·L-1 sodium phosphate monobasic-acetonitrile (90:10);the flow rate was 0.8 mL·min-1. The injection volume was 20 μL and the determination wavelength was set at 220 nm. The column temperature was 35℃. Result: Using this method

calcium dobesilate and its related substances could be absolutely separated. For the content determination

a linearity between the area of calcium dobesilate and its concention was achieved in the range of 20.0-200.0 mg·L-1 (r=0.999 5). The average recovery was 99.4%. The content of total impurities was 0.16%

0.18%

0.13% respectively. The special impurity was 0.018%

0.023%

0.021% respectively. Conclusion: The method was simple

efficient and accurate for analyzing the related substances and content of calcium dobesilate.