Development of novel gradient RP-HPLC method for separation of dapagliflozin and its process-related impurities: insight into stability profile and degradation pathway, identification of degradants using LCMS
Abstract Background In the dapagliflozin (DPF) synthesis, 5-Bromo-2-chlorobenzoic acid (5-BC impurity) and 4-Bromo-1-chloro-2-(4-ethoxybenzyl) benzene (4-BC impurity) are used as starting and reagent sources, respectively. The presence of 5-BC and 4-BC impurities in DPF could potentially affect the...
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SpringerOpen,
2023-11-01T00:00:00Z.
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