Abstract
The study focuses on isolating and characterizing the potential degradation products (DPs) and impurities of Bedaquiline fumarate in bulk drug form. A stability-indicating related substance method was developed and validated using high-performance liquid chromatography. Agilent Poroshell 120EC- C18 (150mm × 4.6mm, 2.7μm) column showed an optimum separation of 10 analytes. The mobile phase contained 0.05% trifluoroacetic acid, acetonitrile and methanol in a time gradient mode. Bedaquiline fumarate was susceptible to acid hydrolysis, oxidation, base hydrolysis and showed three potential DPs, including DP-1, DP-2 and Impurity-8. Degradation products, DP-1 and DP-2, were isolated and characterized by ESI-MS, 1H, NMR and 13C NMR spectroscopy. The developed method was validated according to ICH tripartite guidelines and showed adequate specificity, accuracy and linearity. The limit of detection and limit of quantitation were 0.05 and 0.15μg/mL, respectively.
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