Isolation and Structure Characterization of Two Novel Degradation Products in Flupirtine Maleate Formulation by Prep-HPLC, LC–MS/Q-TOF and 2D-NMR

Background A receptive and easily comprehended technique was evolved for simultaneous assessment of Bempedoic acid and Ezetimibe and its impurities characterized by UPLC–MS/MS. Results This technique involves chromatographic separation with a C18 column of water symmetry (150 mm × 4.6 mm, 3.5 µm). A mobile phase of 0.1% OPA (orthophosphoric acid) and acetonitrile in 50:50 v/v with 1 mL/min flow rate and ambient temperature was used. UV observation was taken at 230 nm. The recoveries, linearity, and quantification limits were found to be within the acceptable limit. Conclusions This technique was successfully tested with UPLC–MS to confirm the chemical structures of newly formed degradation products of Bempedoic acid and Ezetimibe and stress studies as per ICH Q2 (R1) guidelines.

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Isolation and Structure Characterization of Two Novel Degradation Products in Flupirtine Maleate Formulation by Prep-HPLC, LC–MS/Q-TOF and 2D-NMR

Cited by 2 publications

References 15 publications

Isolation, identification and characterization of two novel process-related impurities in olanzapine

Isolation, identification and characterization of two novel process-related impurities in olanzapine

Characterization of novel stress degradation products of Bempedoic acid and Ezetimibe using UPLC–MS/MS: development and validation of stability-indicating UPLC method

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