Novel Route of Synthesis and Characterization of Bilastine with Evaluation of Nitrosamine Impurities

Abstract

The current paper proposes to prepare the novel route of the synthesis of Bilastine drug substance with structural characterization. In addition to this work, formation and evaluation of Nitrosamine impurities of Bilastine are described as per the current regulatory requirements. It is an antihistamine medication used to treat hives, allergic rhinitis and itchy inflamed eyes (allergic conjunctivitis) caused by an allergy. The drug is anti-histamine and selectively inhibits the histamine H1 receptor, the drug product effectively prevents these allergic reactions.