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

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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Bibliographic Details
Main Authors: Bhawani Sunkara, Ganesh Kumar Tummalapalli Naga Venkata
Format: Article
Language:English
Published: SpringerOpen 2023-11-01
Series:Future Journal of Pharmaceutical Sciences
Subjects:
Process impurities
Dapagliflozin
HPLC
Xbridge Phenyl
Gradient elution
Online Access:https://doi.org/10.1186/s43094-023-00556-3

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