Synthesis and Structural Elucidation of Impurities generated in Lansoprazole and Edoxaban
Abstract
Impurities play a critical role in defining the quality, safety, and efficacy of active pharmaceutical ingredients (APIs). Regulatory agencies require comprehensive identification, synthesis, and characterization of impurities present above threshold limits. The present work describes the synthesis and structural elucidation of oxidative degradation impurities generated in two widely used active pharmaceutical ingredients such as Edoxaban and Lansoprazole. Edoxaban N-oxide impurities, Lansoprazole sulfone and Lansoprazole N-oxide impurity were deliberately synthesized under controlled oxidative conditions using hydrogen peroxide and m‑chloroperbenzoic acid (m‑CPBA). The synthesized impurities were isolated, purified, and characterized by High performance liquid chromatography (HPLC), Mass Spectroscopy (MS), Nuclear magnetic resonance (NMR). This study provides a systematic approach for impurity synthesis, isolation, and understanding of degradation pathways, which is essential for impurity profiling, method development, and regulatory submissions.
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