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Liquid chromatography–tandem mass spectrometric assay for the quantitation in human plasma of the novel indenoisoquinoline topoisomerase I inhibitors, NSC 743400 and NSC 725776
Topoisomerase I (Topo I) is a recognized target for ovarian, lung, and colorectal cancer therapy. The FDA-approved camptothecin (CPT) Topo I inhibitors, topotecan and irinotecan are labile and their effects are rapidly reversible. The indenoisoquinoline topoisomerase I inhibitors, NSC 743400 and NSC...
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| Published in: | Journal of pharmaceutical and biomedical analysis 2010-09, Vol.52 (5), p.714-720 |
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| creator | Holleran, Julianne L. Parise, Robert A. Yellow-Duke, Archibong E. Egorin, Merrill J. Eiseman, Julie L. Covey, Joseph M. Beumer, Jan H. |
| description | Topoisomerase I (Topo I) is a recognized target for ovarian, lung, and colorectal cancer therapy. The FDA-approved camptothecin (CPT) Topo I inhibitors, topotecan and irinotecan are labile and their effects are rapidly reversible. The indenoisoquinoline topoisomerase I inhibitors, NSC 743400 and NSC 725776, have been developed as a new generation of Topo I inhibitors and are being advanced to clinical evaluation. To support the clinical development of NSC 743400 and NSC 725776, we developed and validated, according to FDA guidelines, LC–MS/MS assays for the sensitive, accurate and precise quantitation of NSC 743400 and NSC 725776 in 0.2
mL human plasma. After ethyl acetate extraction, separation was achieved with a Synergi Polar RP column and a gradient of 0.1% formic acid in acetonitrile:water. NSC 743400 and NSC 725776 eluted at approximately 3
min, and the total run time was 14
min. Detection consisted of electrospray, positive-mode ionization mass spectrometry. Between 3 and 1000
ng/mL, accuracy was 96.9–108.2% for NSC 743400 and 95.1–106.7% for NSC 725776, and precision was |
| doi_str_mv | 10.1016/j.jpba.2010.02.020 |
| format | article |
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mL human plasma. After ethyl acetate extraction, separation was achieved with a Synergi Polar RP column and a gradient of 0.1% formic acid in acetonitrile:water. NSC 743400 and NSC 725776 eluted at approximately 3
min, and the total run time was 14
min. Detection consisted of electrospray, positive-mode ionization mass spectrometry. Between 3 and 1000
ng/mL, accuracy was 96.9–108.2% for NSC 743400 and 95.1–106.7% for NSC 725776, and precision was <11.4% for NSC 743400 and <5.9% for NSC 725776. Extraction recovery was >80% for both analytes, and ion suppression ranged from −46.7 to 5.7%. The use of isotopically labeled internal standards and a wash phase at the end of the run were necessary to achieve adequate assay performance. Protein binding in human plasma as assessed by equilibrium dialysis showed both indenoisoquinolines to be more than 98% protein bound.</description><identifier>ISSN: 0731-7085</identifier><identifier>ISSN: 1873-264X</identifier><identifier>EISSN: 1873-264X</identifier><identifier>DOI: 10.1016/j.jpba.2010.02.020</identifier><identifier>PMID: 20236781</identifier><identifier>CODEN: JPBADA</identifier><language>eng</language><publisher>Amsterdam: Elsevier B.V</publisher><subject>Analysis ; Analytical, structural and metabolic biochemistry ; Assay ; Benzodioxoles - blood ; Benzodioxoles - pharmacology ; Biological and medical sciences ; Calibration ; Chromatography, Liquid - methods ; Enzyme Inhibitors - blood ; Enzyme Inhibitors - pharmacology ; Fundamental and applied biological sciences. Psychology ; General pharmacology ; Humans ; Indenoisoquinolines ; Isoquinolines - blood ; Isoquinolines - pharmacology ; Limit of Detection ; Medical sciences ; Pharmacology. Drug treatments ; Reproducibility of Results ; Tandem mass spectrometry ; Tandem Mass Spectrometry - methods ; Topoisomerase ; Topoisomerase I Inhibitors ; Validation</subject><ispartof>Journal of pharmaceutical and biomedical analysis, 2010-09, Vol.52 (5), p.714-720</ispartof><rights>2010 Elsevier B.V.</rights><rights>2015 INIST-CNRS</rights><rights>2010 Elsevier B.V. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c516t-1cb15bd0a36edad17e0cfb2419f2f989e5f256ce4c1ee65b588a544f424212403</citedby><cites>FETCH-LOGICAL-c516t-1cb15bd0a36edad17e0cfb2419f2f989e5f256ce4c1ee65b588a544f424212403</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,315,786,790,891,27957,27958</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=22772463$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20236781$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Holleran, Julianne L.</creatorcontrib><creatorcontrib>Parise, Robert A.</creatorcontrib><creatorcontrib>Yellow-Duke, Archibong E.</creatorcontrib><creatorcontrib>Egorin, Merrill J.</creatorcontrib><creatorcontrib>Eiseman, Julie L.</creatorcontrib><creatorcontrib>Covey, Joseph M.</creatorcontrib><creatorcontrib>Beumer, Jan H.</creatorcontrib><title>Liquid chromatography–tandem mass spectrometric assay for the quantitation in human plasma of the novel indenoisoquinoline topoisomerase I inhibitors, NSC 743400 and NSC 725776</title><title>Journal of pharmaceutical and biomedical analysis</title><addtitle>J Pharm Biomed Anal</addtitle><description>Topoisomerase I (Topo I) is a recognized target for ovarian, lung, and colorectal cancer therapy. The FDA-approved camptothecin (CPT) Topo I inhibitors, topotecan and irinotecan are labile and their effects are rapidly reversible. The indenoisoquinoline topoisomerase I inhibitors, NSC 743400 and NSC 725776, have been developed as a new generation of Topo I inhibitors and are being advanced to clinical evaluation. To support the clinical development of NSC 743400 and NSC 725776, we developed and validated, according to FDA guidelines, LC–MS/MS assays for the sensitive, accurate and precise quantitation of NSC 743400 and NSC 725776 in 0.2
mL human plasma. After ethyl acetate extraction, separation was achieved with a Synergi Polar RP column and a gradient of 0.1% formic acid in acetonitrile:water. NSC 743400 and NSC 725776 eluted at approximately 3
min, and the total run time was 14
min. Detection consisted of electrospray, positive-mode ionization mass spectrometry. Between 3 and 1000
ng/mL, accuracy was 96.9–108.2% for NSC 743400 and 95.1–106.7% for NSC 725776, and precision was <11.4% for NSC 743400 and <5.9% for NSC 725776. Extraction recovery was >80% for both analytes, and ion suppression ranged from −46.7 to 5.7%. The use of isotopically labeled internal standards and a wash phase at the end of the run were necessary to achieve adequate assay performance. Protein binding in human plasma as assessed by equilibrium dialysis showed both indenoisoquinolines to be more than 98% protein bound.</description><subject>Analysis</subject><subject>Analytical, structural and metabolic biochemistry</subject><subject>Assay</subject><subject>Benzodioxoles - blood</subject><subject>Benzodioxoles - pharmacology</subject><subject>Biological and medical sciences</subject><subject>Calibration</subject><subject>Chromatography, Liquid - methods</subject><subject>Enzyme Inhibitors - blood</subject><subject>Enzyme Inhibitors - pharmacology</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>General pharmacology</subject><subject>Humans</subject><subject>Indenoisoquinolines</subject><subject>Isoquinolines - blood</subject><subject>Isoquinolines - pharmacology</subject><subject>Limit of Detection</subject><subject>Medical sciences</subject><subject>Pharmacology. Drug treatments</subject><subject>Reproducibility of Results</subject><subject>Tandem mass spectrometry</subject><subject>Tandem Mass Spectrometry - methods</subject><subject>Topoisomerase</subject><subject>Topoisomerase I Inhibitors</subject><subject>Validation</subject><issn>0731-7085</issn><issn>1873-264X</issn><issn>1873-264X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><recordid>eNqFks2KFDEQxxtR3NnVF_AguYiXnTFJJ_0BIsjgx8KgBxW8hep09XaG7qQ3yQzMzXfwTXwkn8S0M656USgIqfrlX1Xhn2WPGF0xyopn29V2amDFaUpQnoLeyRasKvMlL8Tnu9mCljlblrSSZ9l5CFtKqWS1uJ-dccrzoqzYIvu2MTc70xLdezdCdNcepv7w_cvXCLbFkYwQAgkT6pjqGL3RJGXgQDrnSeyR3OzARhMhGmeJsaTfjWDJNEAYgbjuJ2PdHodUbNE6E1xqaN1gLJLopjkxooeA5CohvWlMdD5ckncf1qQUuaCUpFGOVy7LsniQ3etgCPjwdF5kn16_-rh-u9y8f3O1frlZasmKuGS6YbJpKeQFttCyEqnuGi5Y3fGurmqUHZeFRqEZYiEbWVUghegEF5xxQfOL7MVRd9o1I7YabfQwqMmbEfxBOTDq74o1vbp2e8WrQvJcJoGnJwGfdsYQ1WiCxmEAi24XVClknbOasf-TeV7JRM8kP5LauxA8drfzMKpmV6itml2hZlcoylPMmzz-c5PbJ79skIAnJwCChqHzYLUJvzlellwUeeKeHzlM_7436FXQBq3G1vhkEdU68685fgDujdna</recordid><startdate>20100905</startdate><enddate>20100905</enddate><creator>Holleran, Julianne L.</creator><creator>Parise, Robert A.</creator><creator>Yellow-Duke, Archibong E.</creator><creator>Egorin, Merrill J.</creator><creator>Eiseman, Julie L.</creator><creator>Covey, Joseph M.</creator><creator>Beumer, Jan H.</creator><general>Elsevier B.V</general><general>Elsevier</general><scope>IQODW</scope><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><scope>7TM</scope><scope>5PM</scope></search><sort><creationdate>20100905</creationdate><title>Liquid chromatography–tandem mass spectrometric assay for the quantitation in human plasma of the novel indenoisoquinoline topoisomerase I inhibitors, NSC 743400 and NSC 725776</title><author>Holleran, Julianne L. ; Parise, Robert A. ; Yellow-Duke, Archibong E. ; Egorin, Merrill J. ; Eiseman, Julie L. ; Covey, Joseph M. ; Beumer, Jan H.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c516t-1cb15bd0a36edad17e0cfb2419f2f989e5f256ce4c1ee65b588a544f424212403</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Analysis</topic><topic>Analytical, structural and metabolic biochemistry</topic><topic>Assay</topic><topic>Benzodioxoles - blood</topic><topic>Benzodioxoles - pharmacology</topic><topic>Biological and medical sciences</topic><topic>Calibration</topic><topic>Chromatography, Liquid - methods</topic><topic>Enzyme Inhibitors - blood</topic><topic>Enzyme Inhibitors - pharmacology</topic><topic>Fundamental and applied biological sciences. Psychology</topic><topic>General pharmacology</topic><topic>Humans</topic><topic>Indenoisoquinolines</topic><topic>Isoquinolines - blood</topic><topic>Isoquinolines - pharmacology</topic><topic>Limit of Detection</topic><topic>Medical sciences</topic><topic>Pharmacology. Drug treatments</topic><topic>Reproducibility of Results</topic><topic>Tandem mass spectrometry</topic><topic>Tandem Mass Spectrometry - methods</topic><topic>Topoisomerase</topic><topic>Topoisomerase I Inhibitors</topic><topic>Validation</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Holleran, Julianne L.</creatorcontrib><creatorcontrib>Parise, Robert A.</creatorcontrib><creatorcontrib>Yellow-Duke, Archibong E.</creatorcontrib><creatorcontrib>Egorin, Merrill J.</creatorcontrib><creatorcontrib>Eiseman, Julie L.</creatorcontrib><creatorcontrib>Covey, Joseph M.</creatorcontrib><creatorcontrib>Beumer, Jan H.</creatorcontrib><collection>Pascal-Francis</collection><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><collection>Nucleic Acids Abstracts</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Journal of pharmaceutical and biomedical analysis</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Holleran, Julianne L.</au><au>Parise, Robert A.</au><au>Yellow-Duke, Archibong E.</au><au>Egorin, Merrill J.</au><au>Eiseman, Julie L.</au><au>Covey, Joseph M.</au><au>Beumer, Jan H.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Liquid chromatography–tandem mass spectrometric assay for the quantitation in human plasma of the novel indenoisoquinoline topoisomerase I inhibitors, NSC 743400 and NSC 725776</atitle><jtitle>Journal of pharmaceutical and biomedical analysis</jtitle><addtitle>J Pharm Biomed Anal</addtitle><date>2010-09-05</date><risdate>2010</risdate><volume>52</volume><issue>5</issue><spage>714</spage><epage>720</epage><pages>714-720</pages><issn>0731-7085</issn><issn>1873-264X</issn><eissn>1873-264X</eissn><coden>JPBADA</coden><notes>ObjectType-Article-1</notes><notes>SourceType-Scholarly Journals-1</notes><notes>ObjectType-Feature-2</notes><notes>content type line 23</notes><notes>ObjectType-Undefined-3</notes><abstract>Topoisomerase I (Topo I) is a recognized target for ovarian, lung, and colorectal cancer therapy. The FDA-approved camptothecin (CPT) Topo I inhibitors, topotecan and irinotecan are labile and their effects are rapidly reversible. The indenoisoquinoline topoisomerase I inhibitors, NSC 743400 and NSC 725776, have been developed as a new generation of Topo I inhibitors and are being advanced to clinical evaluation. To support the clinical development of NSC 743400 and NSC 725776, we developed and validated, according to FDA guidelines, LC–MS/MS assays for the sensitive, accurate and precise quantitation of NSC 743400 and NSC 725776 in 0.2
mL human plasma. After ethyl acetate extraction, separation was achieved with a Synergi Polar RP column and a gradient of 0.1% formic acid in acetonitrile:water. NSC 743400 and NSC 725776 eluted at approximately 3
min, and the total run time was 14
min. Detection consisted of electrospray, positive-mode ionization mass spectrometry. Between 3 and 1000
ng/mL, accuracy was 96.9–108.2% for NSC 743400 and 95.1–106.7% for NSC 725776, and precision was <11.4% for NSC 743400 and <5.9% for NSC 725776. Extraction recovery was >80% for both analytes, and ion suppression ranged from −46.7 to 5.7%. The use of isotopically labeled internal standards and a wash phase at the end of the run were necessary to achieve adequate assay performance. Protein binding in human plasma as assessed by equilibrium dialysis showed both indenoisoquinolines to be more than 98% protein bound.</abstract><cop>Amsterdam</cop><pub>Elsevier B.V</pub><pmid>20236781</pmid><doi>10.1016/j.jpba.2010.02.020</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Analysis Analytical, structural and metabolic biochemistry Assay Benzodioxoles - blood Benzodioxoles - pharmacology Biological and medical sciences Calibration Chromatography, Liquid - methods Enzyme Inhibitors - blood Enzyme Inhibitors - pharmacology Fundamental and applied biological sciences. Psychology General pharmacology Humans Indenoisoquinolines Isoquinolines - blood Isoquinolines - pharmacology Limit of Detection Medical sciences Pharmacology. Drug treatments Reproducibility of Results Tandem mass spectrometry Tandem Mass Spectrometry - methods Topoisomerase Topoisomerase I Inhibitors Validation |
| title | Liquid chromatography–tandem mass spectrometric assay for the quantitation in human plasma of the novel indenoisoquinoline topoisomerase I inhibitors, NSC 743400 and NSC 725776 |
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