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

Abstract 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...

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Autores principales:	Anuradha Vejendla, Subrahmanyam Talari, G. Ramu, Ch Rajani
Formato:	article
Lenguaje:	EN
Publicado:	SpringerOpen 2021
Materias:	Bempedoic acid Ezetimibe Validation Characterization UPLC UPLC–MS Therapeutics. Pharmacology RM1-950 Pharmacy and materia medica RS1-441
Acceso en línea:	https://doaj.org/article/c0fb128f67e44466bc68c12c3ca6d36f
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spelling	oai:doaj.org-article:c0fb128f67e44466bc68c12c3ca6d36f2021-12-05T12:21:03ZCharacterization of novel stress degradation products of Bempedoic acid and Ezetimibe using UPLC–MS/MS: development and validation of stability-indicating UPLC method10.1186/s43094-021-00381-62314-7253https://doaj.org/article/c0fb128f67e44466bc68c12c3ca6d36f2021-12-01T00:00:00Zhttps://doi.org/10.1186/s43094-021-00381-6https://doaj.org/toc/2314-7253Abstract 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.Anuradha VejendlaSubrahmanyam TalariG. RamuCh RajaniSpringerOpenarticleBempedoic acidEzetimibeValidationCharacterizationUPLCUPLC–MSTherapeutics. PharmacologyRM1-950Pharmacy and materia medicaRS1-441ENFuture Journal of Pharmaceutical Sciences, Vol 7, Iss 1, Pp 1-13 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Bempedoic acid Ezetimibe Validation Characterization UPLC UPLC–MS Therapeutics. Pharmacology RM1-950 Pharmacy and materia medica RS1-441
spellingShingle	Bempedoic acid Ezetimibe Validation Characterization UPLC UPLC–MS Therapeutics. Pharmacology RM1-950 Pharmacy and materia medica RS1-441 Anuradha Vejendla Subrahmanyam Talari G. Ramu Ch Rajani Characterization of novel stress degradation products of Bempedoic acid and Ezetimibe using UPLC–MS/MS: development and validation of stability-indicating UPLC method
description	Abstract 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.
format	article
author	Anuradha Vejendla Subrahmanyam Talari G. Ramu Ch Rajani
author_facet	Anuradha Vejendla Subrahmanyam Talari G. Ramu Ch Rajani
author_sort	Anuradha Vejendla
title	Characterization of novel stress degradation products of Bempedoic acid and Ezetimibe using UPLC–MS/MS: development and validation of stability-indicating UPLC method
title_short	Characterization of novel stress degradation products of Bempedoic acid and Ezetimibe using UPLC–MS/MS: development and validation of stability-indicating UPLC method
title_full	Characterization of novel stress degradation products of Bempedoic acid and Ezetimibe using UPLC–MS/MS: development and validation of stability-indicating UPLC method
title_fullStr	Characterization of novel stress degradation products of Bempedoic acid and Ezetimibe using UPLC–MS/MS: development and validation of stability-indicating UPLC method
title_full_unstemmed	Characterization of novel stress degradation products of Bempedoic acid and Ezetimibe using UPLC–MS/MS: development and validation of stability-indicating UPLC method
title_sort	characterization of novel stress degradation products of bempedoic acid and ezetimibe using uplc–ms/ms: development and validation of stability-indicating uplc method
publisher	SpringerOpen
publishDate	2021
url	https://doaj.org/article/c0fb128f67e44466bc68c12c3ca6d36f
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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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