Determination of Venetoclax Concentration in Plasma Using High-Performance Liquid Chromatography
Abstract Venetoclax is an oral B-cell lymphoma-2 protein inhibitor. It is a key drug for the treatment of chronic lymphocytic leukemia and acute myeloid leukemia. However, venetoclax is administered at a fixed dose, irrespective of body surface area or weight. Furthermore, the plasma concentration o...
Gespeichert in:
Veröffentlicht in: | Journal of chromatographic science 2023-05, Vol.61 (5), p.480-483 |
---|---|
Hauptverfasser: | , , , , |
Format: | Artikel |
Sprache: | eng |
Schlagworte: | |
Online-Zugang: | Volltext |
Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
container_end_page | 483 |
---|---|
container_issue | 5 |
container_start_page | 480 |
container_title | Journal of chromatographic science |
container_volume | 61 |
creator | Yasu, Takeo Gando, Yoshito Nomura, Yuka Kosugi, Nobuharu Kobayashi, Masayuki |
description | Abstract
Venetoclax is an oral B-cell lymphoma-2 protein inhibitor. It is a key drug for the treatment of chronic lymphocytic leukemia and acute myeloid leukemia. However, venetoclax is administered at a fixed dose, irrespective of body surface area or weight. Furthermore, the plasma concentration of venetoclax varies widely between individuals and is influenced by diet. Therefore, individualized dosing using therapeutic drug monitoring (TDM) may help to optimize treatment in clinical practice. In this study, we aimed to develop a simple method to determine venetoclax concentrations in plasma. The analysis required the extraction of a 50-μL plasma sample and precipitation of proteins using acetonitrile extraction. Venetoclax and the internal standard (12.5-μg/mL ibrutinib) were separated by high-performance liquid chromatography (HPLC). The calibration curve was linear over the plasma venetoclax concentration range 0.25–10 μg/mL with a coefficient of determination (r2) of 0.9999. The coefficients of intra-day and inter-day validation were 0.8–4.1% and 1.3–3.3%, respectively. The assay accuracy was −2.8 to 1.6%, and the recovery was >97.2%. These results demonstrate a very simple, novel and sensitive HPLC-UV-based method for determining the concentration of plasma venetoclax, and confirm its applicability to the TDM of venetoclax in a clinical setting. |
doi_str_mv | 10.1093/chromsci/bmac027 |
format | Article |
fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2647653133</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><oup_id>10.1093/chromsci/bmac027</oup_id><sourcerecordid>2647653133</sourcerecordid><originalsourceid>FETCH-LOGICAL-c335t-3adbd7e366a0b4ed55c91f0640946f43fdbed44550619ad3e44acaa51f5924713</originalsourceid><addsrcrecordid>eNqFkE1Lw0AQhhdRbK3ePUmOgsTuZj_SHCV-VCjYgxVvcbLZbVeSbLqbgP33pqT16mkY5nlfhgeha4LvCU7oVG6crbw007wCiaP4BI1JwngY0eTzFI0xjkiYCMFH6ML77_1KZvwcjSinM0q5GKOvR9UqV5kaWmPrwOrgQ9WqtbKEnyC1tVR164abqYNlCb6CYOVNvQ7mZr0Jl8pp6yrowWBhtp0pgnT_FLR27aDZ7C7RmYbSq6vDnKDV89N7Og8Xby-v6cMilP0jbUihyItYUSEA50wVnMuEaCwYTpjQjOoiVwVjnGNBEiioYgwkACeaJxGLCZ2g26G3cXbbKd9mlfFSlSXUynY-iwSLBaeE0h7FAyqd9d4pnTXOVOB2GcHZ3mt29JodvPaRm0N7l1eq-AscRfbA3QDYrvm_7hdp4IeW</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2647653133</pqid></control><display><type>article</type><title>Determination of Venetoclax Concentration in Plasma Using High-Performance Liquid Chromatography</title><source>Oxford University Press Journals All Titles (1996-Current)</source><source>MEDLINE</source><source>EZB-FREE-00999 freely available EZB journals</source><source>Alma/SFX Local Collection</source><source>Free Full-Text Journals in Chemistry</source><creator>Yasu, Takeo ; Gando, Yoshito ; Nomura, Yuka ; Kosugi, Nobuharu ; Kobayashi, Masayuki</creator><creatorcontrib>Yasu, Takeo ; Gando, Yoshito ; Nomura, Yuka ; Kosugi, Nobuharu ; Kobayashi, Masayuki</creatorcontrib><description>Abstract
Venetoclax is an oral B-cell lymphoma-2 protein inhibitor. It is a key drug for the treatment of chronic lymphocytic leukemia and acute myeloid leukemia. However, venetoclax is administered at a fixed dose, irrespective of body surface area or weight. Furthermore, the plasma concentration of venetoclax varies widely between individuals and is influenced by diet. Therefore, individualized dosing using therapeutic drug monitoring (TDM) may help to optimize treatment in clinical practice. In this study, we aimed to develop a simple method to determine venetoclax concentrations in plasma. The analysis required the extraction of a 50-μL plasma sample and precipitation of proteins using acetonitrile extraction. Venetoclax and the internal standard (12.5-μg/mL ibrutinib) were separated by high-performance liquid chromatography (HPLC). The calibration curve was linear over the plasma venetoclax concentration range 0.25–10 μg/mL with a coefficient of determination (r2) of 0.9999. The coefficients of intra-day and inter-day validation were 0.8–4.1% and 1.3–3.3%, respectively. The assay accuracy was −2.8 to 1.6%, and the recovery was >97.2%. These results demonstrate a very simple, novel and sensitive HPLC-UV-based method for determining the concentration of plasma venetoclax, and confirm its applicability to the TDM of venetoclax in a clinical setting.</description><identifier>ISSN: 0021-9665</identifier><identifier>EISSN: 1945-239X</identifier><identifier>DOI: 10.1093/chromsci/bmac027</identifier><identifier>PMID: 35383356</identifier><language>eng</language><publisher>United States: Oxford University Press</publisher><subject>Antineoplastic Agents ; Bridged Bicyclo Compounds, Heterocyclic ; Chromatography, High Pressure Liquid - methods ; Humans ; Reproducibility of Results ; Sulfonamides</subject><ispartof>Journal of chromatographic science, 2023-05, Vol.61 (5), p.480-483</ispartof><rights>The Author(s) 2022. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com 2022</rights><rights>The Author(s) 2022. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c335t-3adbd7e366a0b4ed55c91f0640946f43fdbed44550619ad3e44acaa51f5924713</citedby><cites>FETCH-LOGICAL-c335t-3adbd7e366a0b4ed55c91f0640946f43fdbed44550619ad3e44acaa51f5924713</cites><orcidid>0000-0003-0587-0091 ; 0000-0002-9194-9320</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,1584,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/35383356$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Yasu, Takeo</creatorcontrib><creatorcontrib>Gando, Yoshito</creatorcontrib><creatorcontrib>Nomura, Yuka</creatorcontrib><creatorcontrib>Kosugi, Nobuharu</creatorcontrib><creatorcontrib>Kobayashi, Masayuki</creatorcontrib><title>Determination of Venetoclax Concentration in Plasma Using High-Performance Liquid Chromatography</title><title>Journal of chromatographic science</title><addtitle>J Chromatogr Sci</addtitle><description>Abstract
Venetoclax is an oral B-cell lymphoma-2 protein inhibitor. It is a key drug for the treatment of chronic lymphocytic leukemia and acute myeloid leukemia. However, venetoclax is administered at a fixed dose, irrespective of body surface area or weight. Furthermore, the plasma concentration of venetoclax varies widely between individuals and is influenced by diet. Therefore, individualized dosing using therapeutic drug monitoring (TDM) may help to optimize treatment in clinical practice. In this study, we aimed to develop a simple method to determine venetoclax concentrations in plasma. The analysis required the extraction of a 50-μL plasma sample and precipitation of proteins using acetonitrile extraction. Venetoclax and the internal standard (12.5-μg/mL ibrutinib) were separated by high-performance liquid chromatography (HPLC). The calibration curve was linear over the plasma venetoclax concentration range 0.25–10 μg/mL with a coefficient of determination (r2) of 0.9999. The coefficients of intra-day and inter-day validation were 0.8–4.1% and 1.3–3.3%, respectively. The assay accuracy was −2.8 to 1.6%, and the recovery was >97.2%. These results demonstrate a very simple, novel and sensitive HPLC-UV-based method for determining the concentration of plasma venetoclax, and confirm its applicability to the TDM of venetoclax in a clinical setting.</description><subject>Antineoplastic Agents</subject><subject>Bridged Bicyclo Compounds, Heterocyclic</subject><subject>Chromatography, High Pressure Liquid - methods</subject><subject>Humans</subject><subject>Reproducibility of Results</subject><subject>Sulfonamides</subject><issn>0021-9665</issn><issn>1945-239X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkE1Lw0AQhhdRbK3ePUmOgsTuZj_SHCV-VCjYgxVvcbLZbVeSbLqbgP33pqT16mkY5nlfhgeha4LvCU7oVG6crbw007wCiaP4BI1JwngY0eTzFI0xjkiYCMFH6ML77_1KZvwcjSinM0q5GKOvR9UqV5kaWmPrwOrgQ9WqtbKEnyC1tVR164abqYNlCb6CYOVNvQ7mZr0Jl8pp6yrowWBhtp0pgnT_FLR27aDZ7C7RmYbSq6vDnKDV89N7Og8Xby-v6cMilP0jbUihyItYUSEA50wVnMuEaCwYTpjQjOoiVwVjnGNBEiioYgwkACeaJxGLCZ2g26G3cXbbKd9mlfFSlSXUynY-iwSLBaeE0h7FAyqd9d4pnTXOVOB2GcHZ3mt29JodvPaRm0N7l1eq-AscRfbA3QDYrvm_7hdp4IeW</recordid><startdate>20230530</startdate><enddate>20230530</enddate><creator>Yasu, Takeo</creator><creator>Gando, Yoshito</creator><creator>Nomura, Yuka</creator><creator>Kosugi, Nobuharu</creator><creator>Kobayashi, Masayuki</creator><general>Oxford University Press</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0003-0587-0091</orcidid><orcidid>https://orcid.org/0000-0002-9194-9320</orcidid></search><sort><creationdate>20230530</creationdate><title>Determination of Venetoclax Concentration in Plasma Using High-Performance Liquid Chromatography</title><author>Yasu, Takeo ; Gando, Yoshito ; Nomura, Yuka ; Kosugi, Nobuharu ; Kobayashi, Masayuki</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c335t-3adbd7e366a0b4ed55c91f0640946f43fdbed44550619ad3e44acaa51f5924713</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Antineoplastic Agents</topic><topic>Bridged Bicyclo Compounds, Heterocyclic</topic><topic>Chromatography, High Pressure Liquid - methods</topic><topic>Humans</topic><topic>Reproducibility of Results</topic><topic>Sulfonamides</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Yasu, Takeo</creatorcontrib><creatorcontrib>Gando, Yoshito</creatorcontrib><creatorcontrib>Nomura, Yuka</creatorcontrib><creatorcontrib>Kosugi, Nobuharu</creatorcontrib><creatorcontrib>Kobayashi, Masayuki</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of chromatographic science</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Yasu, Takeo</au><au>Gando, Yoshito</au><au>Nomura, Yuka</au><au>Kosugi, Nobuharu</au><au>Kobayashi, Masayuki</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Determination of Venetoclax Concentration in Plasma Using High-Performance Liquid Chromatography</atitle><jtitle>Journal of chromatographic science</jtitle><addtitle>J Chromatogr Sci</addtitle><date>2023-05-30</date><risdate>2023</risdate><volume>61</volume><issue>5</issue><spage>480</spage><epage>483</epage><pages>480-483</pages><issn>0021-9665</issn><eissn>1945-239X</eissn><abstract>Abstract
Venetoclax is an oral B-cell lymphoma-2 protein inhibitor. It is a key drug for the treatment of chronic lymphocytic leukemia and acute myeloid leukemia. However, venetoclax is administered at a fixed dose, irrespective of body surface area or weight. Furthermore, the plasma concentration of venetoclax varies widely between individuals and is influenced by diet. Therefore, individualized dosing using therapeutic drug monitoring (TDM) may help to optimize treatment in clinical practice. In this study, we aimed to develop a simple method to determine venetoclax concentrations in plasma. The analysis required the extraction of a 50-μL plasma sample and precipitation of proteins using acetonitrile extraction. Venetoclax and the internal standard (12.5-μg/mL ibrutinib) were separated by high-performance liquid chromatography (HPLC). The calibration curve was linear over the plasma venetoclax concentration range 0.25–10 μg/mL with a coefficient of determination (r2) of 0.9999. The coefficients of intra-day and inter-day validation were 0.8–4.1% and 1.3–3.3%, respectively. The assay accuracy was −2.8 to 1.6%, and the recovery was >97.2%. These results demonstrate a very simple, novel and sensitive HPLC-UV-based method for determining the concentration of plasma venetoclax, and confirm its applicability to the TDM of venetoclax in a clinical setting.</abstract><cop>United States</cop><pub>Oxford University Press</pub><pmid>35383356</pmid><doi>10.1093/chromsci/bmac027</doi><tpages>4</tpages><orcidid>https://orcid.org/0000-0003-0587-0091</orcidid><orcidid>https://orcid.org/0000-0002-9194-9320</orcidid></addata></record> |
fulltext | fulltext |
identifier | ISSN: 0021-9665 |
ispartof | Journal of chromatographic science, 2023-05, Vol.61 (5), p.480-483 |
issn | 0021-9665 1945-239X |
language | eng |
recordid | cdi_proquest_miscellaneous_2647653133 |
source | Oxford University Press Journals All Titles (1996-Current); MEDLINE; EZB-FREE-00999 freely available EZB journals; Alma/SFX Local Collection; Free Full-Text Journals in Chemistry |
subjects | Antineoplastic Agents Bridged Bicyclo Compounds, Heterocyclic Chromatography, High Pressure Liquid - methods Humans Reproducibility of Results Sulfonamides |
title | Determination of Venetoclax Concentration in Plasma Using High-Performance Liquid Chromatography |
url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-28T10%3A30%3A03IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Determination%20of%20Venetoclax%20Concentration%20in%20Plasma%20Using%20High-Performance%20Liquid%20Chromatography&rft.jtitle=Journal%20of%20chromatographic%20science&rft.au=Yasu,%20Takeo&rft.date=2023-05-30&rft.volume=61&rft.issue=5&rft.spage=480&rft.epage=483&rft.pages=480-483&rft.issn=0021-9665&rft.eissn=1945-239X&rft_id=info:doi/10.1093/chromsci/bmac027&rft_dat=%3Cproquest_cross%3E2647653133%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2647653133&rft_id=info:pmid/35383356&rft_oup_id=10.1093/chromsci/bmac027&rfr_iscdi=true |