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An Improved Process for the Preparation of Dabigatran Etexilate Mesylate and Synthesis of its Impurities
Author(s): Sitaramaiah Devarasetty, Ravi Janni, Rambabu Nunna, Raghu Ram Suraparaju
The present invention describes the improved process for the preparation of dabigatran etexilate mesylate and impurities synthesis. The Synthesis involves easily available commercial raw materials with Acylation from n-hexyl chloroformate makes to get desired Dabigatran Etexilate from the methane sulfonic acid it is finally as a dabigatran etexilate mesylate salt with an effective yield. Catalyst free and pressure handled reactions are not performed. Dabigatran is an effective oral prodrug of the thrombin (Factor IIa) inhibitor it has been approved by FDA and is widely used to reduce the risk of stroke in patients with non-valvular atrial fibrillation.