Quantitative Study of Impurities in Bedaquiline Fumarate: Identification and Characterization of Its Three Degradation Products Using HPLC, LC/ESI-MS, and NMR Analyses
Abstract:The study aimed to establish a high-performance liquid chromatography (HPLC) method for the quantitative analysis of the related substances of bedaquiline fumarate. Nuclear magnetic resonance and mass spectrometry were used for characterization and assay. A chromatographic method was used for separation. The conditions used were: gradient elution system composed of methanol 0.01mol/L KH2PO4 and 0.01 mol/L K2HPO4 (pH = 4.1) with a flow rate of 1 mL/min, at 224 nm as the detection wavelength. In this study, thre… Show more
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