Development of a Stability-Indicating Analytical Method for Determination of Venetoclax Using AQbD Principles
[Image: see text] Venetoclax is an emerging drug for the treatment of various types of blood cancers. It was first approved in 2016 for the treatment of relapsed and refractory chronic lymphocytic leukemia. Later, the indications expanded, and multiple research as well as clinical studies are still...
Autores principales: | , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
American Chemical Society
2020
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7377371/ https://www.ncbi.nlm.nih.gov/pubmed/32715260 http://dx.doi.org/10.1021/acsomega.0c02338 |
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author | Žigart, Nina Časar, Zdenko |
author_facet | Žigart, Nina Časar, Zdenko |
author_sort | Žigart, Nina |
collection | PubMed |
description | [Image: see text] Venetoclax is an emerging drug for the treatment of various types of blood cancers. It was first approved in 2016 for the treatment of relapsed and refractory chronic lymphocytic leukemia. Later, the indications expanded, and multiple research as well as clinical studies are still conducted involving venetoclax. No analytical method for the determination of venetoclax can currently be found in the literature. We developed a mass spectrometry-compatible stability-indicating ultrahigh-performance liquid chromatography (LC) method for venetoclax. The LC method was developed using analytical quality by design principles. The developed method is able to separate venetoclax and its degradation products. The method was validated in the working point where a linearity range was established and accuracy, repeatability, and selectivity were assessed. Venetoclax is the only Bcl-2 protein inhibitor on the market. It is very effective in combinational therapy, so future drug development involving venetoclax may be expected. A stability-indicating method could aid in the development of new pharmaceutical products with venetoclax. |
format | Online Article Text |
id | pubmed-7377371 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | American Chemical Society |
record_format | MEDLINE/PubMed |
spelling | pubmed-73773712020-07-24 Development of a Stability-Indicating Analytical Method for Determination of Venetoclax Using AQbD Principles Žigart, Nina Časar, Zdenko ACS Omega [Image: see text] Venetoclax is an emerging drug for the treatment of various types of blood cancers. It was first approved in 2016 for the treatment of relapsed and refractory chronic lymphocytic leukemia. Later, the indications expanded, and multiple research as well as clinical studies are still conducted involving venetoclax. No analytical method for the determination of venetoclax can currently be found in the literature. We developed a mass spectrometry-compatible stability-indicating ultrahigh-performance liquid chromatography (LC) method for venetoclax. The LC method was developed using analytical quality by design principles. The developed method is able to separate venetoclax and its degradation products. The method was validated in the working point where a linearity range was established and accuracy, repeatability, and selectivity were assessed. Venetoclax is the only Bcl-2 protein inhibitor on the market. It is very effective in combinational therapy, so future drug development involving venetoclax may be expected. A stability-indicating method could aid in the development of new pharmaceutical products with venetoclax. American Chemical Society 2020-07-09 /pmc/articles/PMC7377371/ /pubmed/32715260 http://dx.doi.org/10.1021/acsomega.0c02338 Text en Copyright © 2020 American Chemical Society This is an open access article published under a Creative Commons Attribution (CC-BY) License (http://pubs.acs.org/page/policy/authorchoice_ccby_termsofuse.html) , which permits unrestricted use, distribution and reproduction in any medium, provided the author and source are cited. |
spellingShingle | Žigart, Nina Časar, Zdenko Development of a Stability-Indicating Analytical Method for Determination of Venetoclax Using AQbD Principles |
title | Development of a Stability-Indicating Analytical Method
for Determination of Venetoclax Using AQbD Principles |
title_full | Development of a Stability-Indicating Analytical Method
for Determination of Venetoclax Using AQbD Principles |
title_fullStr | Development of a Stability-Indicating Analytical Method
for Determination of Venetoclax Using AQbD Principles |
title_full_unstemmed | Development of a Stability-Indicating Analytical Method
for Determination of Venetoclax Using AQbD Principles |
title_short | Development of a Stability-Indicating Analytical Method
for Determination of Venetoclax Using AQbD Principles |
title_sort | development of a stability-indicating analytical method
for determination of venetoclax using aqbd principles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7377371/ https://www.ncbi.nlm.nih.gov/pubmed/32715260 http://dx.doi.org/10.1021/acsomega.0c02338 |
work_keys_str_mv | AT zigartnina developmentofastabilityindicatinganalyticalmethodfordeterminationofvenetoclaxusingaqbdprinciples AT casarzdenko developmentofastabilityindicatinganalyticalmethodfordeterminationofvenetoclaxusingaqbdprinciples |