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Separation and Characterization of Novel Degradation and Process Related Impurities of Bedaquiline Bulk Drug

Bedaquiline (BDQ) is a new drug approved by United States Food and Drug Administration (USFDA) in 2012 for the treatment of drug-resistant tuberculosis, which has become a major threat globally. The manuscript presents the development of three liquid chromatography (LC) based analytical methods. The...

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Detalles Bibliográficos
Autores principales: Vanavi, Pragati J, Rajput, Sadhana J
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9439945/
https://www.ncbi.nlm.nih.gov/pubmed/34607340
http://dx.doi.org/10.1093/chromsci/bmab117
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author Vanavi, Pragati J
Rajput, Sadhana J
author_facet Vanavi, Pragati J
Rajput, Sadhana J
author_sort Vanavi, Pragati J
collection PubMed
description Bedaquiline (BDQ) is a new drug approved by United States Food and Drug Administration (USFDA) in 2012 for the treatment of drug-resistant tuberculosis, which has become a major threat globally. The manuscript presents the development of three liquid chromatography (LC) based analytical methods. The first is a stability indicating RP-HPLC (reverse phase-high performance liquid chromatography) method to analyze the BDQ in presence of its degradation products. Another UPLC/ESI–MS (ultra-performance liquid chromatography/electron spray ionization–mass spectrometry) method was developed for the identification of different degradation based and process related impurities and the third, preparative HPLC method was developed for the isolation of major degradation products. Eleven degradation products and one process related impurity were identified using UPLC/ESI–MS whereas preparative HPLC was used to isolate two degradation products and their chemical structure was elucidated using nuclear magnetic resonance, mass and infra-red spectral data.
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spelling pubmed-94399452022-09-06 Separation and Characterization of Novel Degradation and Process Related Impurities of Bedaquiline Bulk Drug Vanavi, Pragati J Rajput, Sadhana J J Chromatogr Sci Article Bedaquiline (BDQ) is a new drug approved by United States Food and Drug Administration (USFDA) in 2012 for the treatment of drug-resistant tuberculosis, which has become a major threat globally. The manuscript presents the development of three liquid chromatography (LC) based analytical methods. The first is a stability indicating RP-HPLC (reverse phase-high performance liquid chromatography) method to analyze the BDQ in presence of its degradation products. Another UPLC/ESI–MS (ultra-performance liquid chromatography/electron spray ionization–mass spectrometry) method was developed for the identification of different degradation based and process related impurities and the third, preparative HPLC method was developed for the isolation of major degradation products. Eleven degradation products and one process related impurity were identified using UPLC/ESI–MS whereas preparative HPLC was used to isolate two degradation products and their chemical structure was elucidated using nuclear magnetic resonance, mass and infra-red spectral data. Oxford University Press 2021-10-05 /pmc/articles/PMC9439945/ /pubmed/34607340 http://dx.doi.org/10.1093/chromsci/bmab117 Text en © The Author(s) 2021. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com https://creativecommons.org/licenses/by-nc/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Article
Vanavi, Pragati J
Rajput, Sadhana J
Separation and Characterization of Novel Degradation and Process Related Impurities of Bedaquiline Bulk Drug
title Separation and Characterization of Novel Degradation and Process Related Impurities of Bedaquiline Bulk Drug
title_full Separation and Characterization of Novel Degradation and Process Related Impurities of Bedaquiline Bulk Drug
title_fullStr Separation and Characterization of Novel Degradation and Process Related Impurities of Bedaquiline Bulk Drug
title_full_unstemmed Separation and Characterization of Novel Degradation and Process Related Impurities of Bedaquiline Bulk Drug
title_short Separation and Characterization of Novel Degradation and Process Related Impurities of Bedaquiline Bulk Drug
title_sort separation and characterization of novel degradation and process related impurities of bedaquiline bulk drug
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9439945/
https://www.ncbi.nlm.nih.gov/pubmed/34607340
http://dx.doi.org/10.1093/chromsci/bmab117
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