Quantitative Study of Impurities in Bedaquiline Fumarate: Identification and Characterization of Its Three Degradation Products Using HPLC, LC/ESI-MS, and NMR Analyses

The study aimed to establish a high-performance liquid chromatography (HPLC) method for the quantitative analysis of related substances bedaquiline fumarate. Nuclear magnetic resonance and mass spectrometry were used characterization assay. A chromatographic was separation. conditions were: gradient elution system composed methanol 0.01mol/L KH2PO4 0.01 mol/L K2HPO4 (pH = 4.1) with flow rate 1 mL/min, at 224 nm as detection wavelength. In this study, three degradation products fumarate have been disclosed first time. impurities drug well separated. provided linear responses within concentration range, which varied from 0.20 10.08 μg/mL limits 0.10 quantification μg/mL. mean percent recovery between 91.64 105.89%. validated other parameters such specificity, stability, robustness. This worked impurity studies quality control laboratory-prepared samples