OBJECTIVE： To establish a method for the determination of related substances in regorafenib. METHODS： Gradient elution HPLC was performed on the column of Waters Atlantis T3 C18 with mobile phase A of 0.1％ Trifluoroacetic acid solution and B of acetonitrile （gradient elution） at a flow rate of 1.0 ml/min， the detection wavelength was 232 nm and column temperature was 35 ℃， injection volume was 10 μl. RESULTS： AFP-PMA urease （impurity A）， FP- dimethyl pyridine carboxamide （impurity B），3，4-bis-CTF-aminoformamido-PMA （impurity C）， regorafenib and other impurities were well separated； the linear range was 0.511-5.108 μg/ml for impurity A（r＝0.999 9）， 0.287-2.869 μg/ml for impurity B（r＝0.999 5）， 0.360-3.604 μg/ml for impurity C（r＝0.999 9） and 1.444-14.442 μg/ml for regorafenib （r＝0.999 8）； the detection limit were 0.052，0.022，0.084 and 0.071 μg/ml，respectively； RSDs of precision， stability and reproducibility tests were lower than 3％； recoveries of impurity A， B and C were 102.7％-106.3％ （RSD＝1.09％，n＝9）， 98.2％-102.9％ （RSD＝1.83％，n＝9） and 98.6％-104.3％ （RSD＝1.57％，n＝9）. CONCLUSIONS： The method is sensitive， rapid， accurate and reliable， and can be used for the determination of related substances in regorafenib.