Analysis and purification method of edoxaban p-toluenesulfonate hydrate and preparation method of main impurities of edoxaban p-toluenesulfonate hydrate

The invention belongs to the technical field of medicines, and relates to an analysis and purification method of an edoxaban p-toluenesulfonate hydrate and a preparation method of main impurities of the edoxaban p-toluenesulfonate hydrate. N1, N2-bis (5-chloropyridine-2-yl) oxamide is a main impurity generated in the synthesis process of the edoxaban p-toluenesulfonate hydrate. The preparation ofthe N1, N2-bis (5-chloropyridine 2-yl) oxamide provides a high-quality impurity reference substance for the edoxaban p-toluenesulfonate hydrate; The analysis method of the related substances of the edoxaban p-toluenesulfonate hydrate can effectively detect the N1, N2-bis (5-chloropyridine-2-yl) oxamide, meanwhile, the method is suitable for detection of other related substances, and guarantees thequality controllability of the edoxaban p-toluenesulfonate hydrate. The purification method of the edoxaban p-toluenesulfonate hydrate can effectively remove the impurity, namely, N1, N2-bis (5-chloropyridine 2-yl) oxamide ,