An Efficient, Novel Synthetic Route to (R)-Salmeterol Xinafoate and Facile Synthetic Protocols for Preparation of its Process Related Potential Impurities

Abstract

In present work, an effective, innovative enantioselective synthetic strategy for the synthesis of salmeterol xinafoate and its probable process-related impurities was reported. Seven pharmacopeia specified impurities were synthesized and confirmed by FT-IR, mass, 1H & 13C NMR spectroscopy. With respect to the corresponding retention factors, these contaminants were validated using the available RP-HPLC method. These compounds can be used as a reference standard for the active pharmaceutical ingredient manufactures and research organizations.