Synthesis and characterization of new related substances of the antiarrhythmic drug dronedarone hydrochloride.

Journal of pharmaceutical and biomedical analysis

PubMedID: 26133102

Santos M, García LC, Checura C, Donadío LG, Fernandez C, Orgueira H, Comin MJ. Synthesis and characterization of new related substances of the antiarrhythmic drug dronedarone hydrochloride. J Pharm Biomed Anal. 2015;114441-446.
Two new potential impurities of antiarrhythmic drug substance Dronedarone Hydrochloride together with debutyldronedarone were detected by LC-MS analysis during process development. A successful synthetic strategy for the synthesis of these potential impurities was developed facilitating the access to new impurity reference standards. Their synthesis and characterization are discussed in detail. The availability of these impurity standards allowed cost reduction through the increase of process control.