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

• Two new potential impurities of API Dronedarone were identified and synthesized.
• Debutyldronedarone metabolite was characterized and synthesized for first time.
• LC–MS analysis of validation batches showed their presence at low levels.
• Their synthesis allows cost reduction by increasing process control.

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.

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