Synthesis and Characterization of Ether-Dimer Impurity of Drug - Ranolazine Using 2, 2’- (oxybis (methylene)) Bis (Oxirane)

Ranolazine became the first approved member of a new family of antianginal medications in nearly 25 years when it was licensed in 2006 for the treatment of chronic angina pectoris. The exact mechanism of action of Ranolazine is unclear. Ranolazine was originally believed to work by partially inhibiting the oxidation of fatty acids. Ranolazine may lessen calcium excess in ischemic myocytes by inhibiting the late sodium current, according to more recent data. Headache, nausea, constipation, and dizziness are the most commonly reported side effects. Ranolazine is listed among the top 200 drugs by sales in the decade of the 2010s. In this study, several impurities related to Ranolazine, a piperazine derivative used as a second-line treatment for patients with stable or poorly managed chronic angina who are not responding to other medications, the synthesis of impurities produced during the bulk drug's in-house production of Ranolazine was explained. The unknown impurities were identified as2,2'-(4,4'-(oxybis(2-hydroxypropane-3,1-diyl))bis(piperazine-4,1- diyl))bis(N-(2,6-dimethylphenyl)acetamide). The study uses a variety of spectral techniques, such as Infrared Spectroscopy (IR): A technique for determining molecular vibrations and functional groups. Atomic connectivity and structure can be thoroughly understood through nuclear magnetic resonance (NMR). The molecular weight and fragmentation patterns of compounds are ascertained through mass spectrometry (mass). Utilizing High-Performance Liquid Chromatography (HPLC), various compounds in a mixture can be separated and examined.