Synthesis, Purification and Characterization of Some Impurities of Propranolol

Introduction: During the process of drug development, control of impurities and it should keep within the prescribed limit is very important to get high-qualified drugs. Several studies have been dedicated to synthesizing the impurities and studying the structures to support the method of purification. Propranolol is beta blocker medication preferably blocks β1 receptor, primarily used to treat high blood pressure and heart-associated chest pain. Hence synthesis and study of impurities related to propranolol is very important variables. Aim: The aim of this research work has to synthesize propranolol impurities because these impurities play a vital role in the drug process. Experimental work: We focus on synthesis of five main propranolol impurities with purification and characterization. We synthesize five impurities namely: 2-[(naphthalen-1-yloxy) methyl] oxirane; 3,3′-(isopropyl azanediyl) bis(1-(naphthalen-1-yloxy) propan-2-ol) hydrochloride; 1,3-bis(naphthalen-1-yloxy) propan-2-ol; 1-amino-3-naphthalen- 1-yloxypropan-2-ol; and N-(2-Hydroxy-3-(naphthalen-1-yloxy) propyl)-N-isopropyl acetamide. These five impurities were designed and synthesize by ring opening, dimerization and reduction by taking 1 naphthol as starting material. Characterization: Column chromatography and thin-layer chromatography techniques were used for the separation and purification of chemical compounds. The structures of synthesized compounds were elucidated by using mass spectrometry and 1H-NMR spectroscopy. For future prospect pharmaceutical industry reduce the level of impurity to their required threshold according to ICH guideline. Conclusion: We synthesized impurity which belong to emergency cardiovascular drug, so that they have high market value in pharmaceutical industry for concerning safety of potent drug. In our research work, we study how to synthesize impurities of API and their characterization.