Abstract:
OBJECTIVE To perform the quality of rivaroxaban which was a kind of anticoagulant drug, three degradation impurities
A, B and
C were synthesized and characterized.
METHODS Rivaroxaban (
1 ) was used as starting material to prepare Impurity
A , impurity
B was synthesized by hydrolyzing impurity
A , and impurity
C was obtained from impurity
A by substitution reaction.
RESULTS The structures of the three impurities had been verified by
1H-NMR and
13C-NMR and MS. Their purities were over 99.0% (detected by HPLC).
CONCLUSION The synthetic degradation impurities can be used as the reference substance of the impurities in the quality control of rivaroxaban.