Study On Lab-scale Process Development And Manufacture Of Atipamezole HCI

Atipamezole HCl, the chemical name is 4-(2-ethyl-2,3-dihydro-1H-inden-2-yl)-1H-imidazole hydrochloride.Atipamezole HCl is a potent a2-antagonist which selectively and competitively inhibits a 2-adrenergic'receptors. Activation of Atipamezole HCl is to induce a pattern of pharmacological responses including sedation, reduction of anxiety, analgesia, bradycardia, and transient hypertension with a subsequently reduced blood pressure. The result of atipamezole administration in animal is the rapid recovery from sedation.There are some demands on Atipamezole HCl in overseas market, but its supplies are still inadequate.Based on reference to the pertinent literature, the current synthesis route was subject to a comparison research, a commercialization process was established as well as an optimized lab-scale process. With analyzing by IR spectrum, UV spectrum, NMR and mass spectrum, the structure of produced Atipamezole HCl was successfully verified.Based on completed development of lab-scale process, the pilot scale process of Atipamezole HCl was developed subsequently. HPLC method was also utilized to control the quality of intermediate as to ensure production of conforming Atipamezole HCl final products.This study will provide reliable and effective data for future commercialization of Atipamezole HCl.