Development of LC/MS/MS assay for the determination of 5-ethyl-2-{5-[4-(2-hydroxyethyl)piperazine-1-sulfonyl]-2-propoxyphenyl}-7-propyl-3,5-dihydropyrrolo[3,2-d]pyrimidin-4-one (SK3530) in human plasma: application to a clinical pharmacokinetic study
5-Ethyl-2-{5-[4-(2-hydroxyethyl)piperazine-1-sulfonyl]-2-propoxyphenyl}-7-propyl-3,5-dihydropyrrolo[3,2-d]pyrimidin-4-one (SK3530) is a new phosphodiesterase type-5 inhibitor currently undergoing a Phase III investigation for the treatment of male erectile dysfunction. This study first describes a r...
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creator | Shin, Beom Soo Hu, Seul Ki Kim, John Oh, Joon Gyo Youn, Won-No Lee, Bongyong Um, Key An Kim, Dae-Kee Lee, Ju Young Yoo, Sun Dong |
description | 5-Ethyl-2-{5-[4-(2-hydroxyethyl)piperazine-1-sulfonyl]-2-propoxyphenyl}-7-propyl-3,5-dihydropyrrolo[3,2-d]pyrimidin-4-one (SK3530) is a new phosphodiesterase type-5 inhibitor currently undergoing a Phase III investigation for the treatment of male erectile dysfunction. This study first describes a rapid and sensitive LC/MS/MS assay method for the quantification of SK3530 and its major metabolite, SK3541, in human plasma. The assay was validated to demonstrate the specificity, linearity, recovery, lower limit of quantification (LLOQ), accuracy, and precision. The multiple reaction monitoring was based on the transition of m/z=532.5→99.1 for SK3530, 488.6→295.5 for SK3541, and 520.3→99.1 for SK3304 (internal standard). The assay utilized a single liquid–liquid extraction and isocratic elution, and the LLOQ was 1ng/ml using 0.2ml human plasma. The assay was linear over a range from 1 to 1000ng/ml for both SK3530 and SK3541, with correlation coefficients >0.9999. The mean intra- and inter-day assay accuracy ranged from 94.7 to 101.6% and 96.8 to 101.1% for SK3530 and 92.6–105.7% and 97.4–107.8% for SK3541, respectively. The mean intra- and inter-day precision was between 7.2–12.1% and 5.7–7.4% for SK3530 and 4.6–13.2% and 5.0–14.1% for SK3541, respectively. The developed assay was applied to a clinical pharmacokinetic study after oral administration of SK3530 in healthy male volunteers (dose 100mg). |
doi_str_mv | 10.1016/j.jpba.2007.06.021 |
format | Article |
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This study first describes a rapid and sensitive LC/MS/MS assay method for the quantification of SK3530 and its major metabolite, SK3541, in human plasma. The assay was validated to demonstrate the specificity, linearity, recovery, lower limit of quantification (LLOQ), accuracy, and precision. The multiple reaction monitoring was based on the transition of m/z=532.5→99.1 for SK3530, 488.6→295.5 for SK3541, and 520.3→99.1 for SK3304 (internal standard). The assay utilized a single liquid–liquid extraction and isocratic elution, and the LLOQ was 1ng/ml using 0.2ml human plasma. The assay was linear over a range from 1 to 1000ng/ml for both SK3530 and SK3541, with correlation coefficients >0.9999. The mean intra- and inter-day assay accuracy ranged from 94.7 to 101.6% and 96.8 to 101.1% for SK3530 and 92.6–105.7% and 97.4–107.8% for SK3541, respectively. The mean intra- and inter-day precision was between 7.2–12.1% and 5.7–7.4% for SK3530 and 4.6–13.2% and 5.0–14.1% for SK3541, respectively. The developed assay was applied to a clinical pharmacokinetic study after oral administration of SK3530 in healthy male volunteers (dose 100mg).</description><identifier>ISSN: 0731-7085</identifier><identifier>EISSN: 1873-264X</identifier><identifier>DOI: 10.1016/j.jpba.2007.06.021</identifier><identifier>PMID: 17689219</identifier><identifier>CODEN: JPBADA</identifier><language>eng</language><publisher>Amsterdam: Elsevier B.V</publisher><subject>Administration, Oral ; Adult ; Analysis ; Analytical, structural and metabolic biochemistry ; Biological and medical sciences ; Calibration ; Chromatography, High Pressure Liquid ; Erectile Dysfunction - drug therapy ; Fundamental and applied biological sciences. Psychology ; General pharmacology ; Humans ; LC/MS/MS ; Male ; Medical sciences ; Molecular Structure ; PDE-5 inhibitor ; Pharmacokinetics ; Pharmacology, Clinical - methods ; Pharmacology. Drug treatments ; Pyrimidinones - blood ; Pyrimidinones - pharmacokinetics ; Pyrimidinones - therapeutic use ; Quality Control ; Reference Standards ; Reproducibility of Results ; Sensitivity and Specificity ; SK3530 ; SK3541 ; Spectrometry, Mass, Electrospray Ionization ; Sulfones - blood ; Sulfones - pharmacokinetics ; Sulfones - therapeutic use ; Tandem Mass Spectrometry</subject><ispartof>Journal of pharmaceutical and biomedical analysis, 2007-09, Vol.45 (1), p.176-184</ispartof><rights>2007 Elsevier B.V.</rights><rights>2007 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c384t-c32d7f8cb3ac9d68ff0a7cb6a954faf189cbb1d93f5dd89195f8354813b0674a3</citedby><cites>FETCH-LOGICAL-c384t-c32d7f8cb3ac9d68ff0a7cb6a954faf189cbb1d93f5dd89195f8354813b0674a3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.jpba.2007.06.021$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=19087423$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/17689219$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Shin, Beom Soo</creatorcontrib><creatorcontrib>Hu, Seul Ki</creatorcontrib><creatorcontrib>Kim, John</creatorcontrib><creatorcontrib>Oh, Joon Gyo</creatorcontrib><creatorcontrib>Youn, Won-No</creatorcontrib><creatorcontrib>Lee, Bongyong</creatorcontrib><creatorcontrib>Um, Key An</creatorcontrib><creatorcontrib>Kim, Dae-Kee</creatorcontrib><creatorcontrib>Lee, Ju Young</creatorcontrib><creatorcontrib>Yoo, Sun Dong</creatorcontrib><title>Development of LC/MS/MS assay for the determination of 5-ethyl-2-{5-[4-(2-hydroxyethyl)piperazine-1-sulfonyl]-2-propoxyphenyl}-7-propyl-3,5-dihydropyrrolo[3,2-d]pyrimidin-4-one (SK3530) in human plasma: application to a clinical pharmacokinetic study</title><title>Journal of pharmaceutical and biomedical analysis</title><addtitle>J Pharm Biomed Anal</addtitle><description>5-Ethyl-2-{5-[4-(2-hydroxyethyl)piperazine-1-sulfonyl]-2-propoxyphenyl}-7-propyl-3,5-dihydropyrrolo[3,2-d]pyrimidin-4-one (SK3530) is a new phosphodiesterase type-5 inhibitor currently undergoing a Phase III investigation for the treatment of male erectile dysfunction. This study first describes a rapid and sensitive LC/MS/MS assay method for the quantification of SK3530 and its major metabolite, SK3541, in human plasma. The assay was validated to demonstrate the specificity, linearity, recovery, lower limit of quantification (LLOQ), accuracy, and precision. The multiple reaction monitoring was based on the transition of m/z=532.5→99.1 for SK3530, 488.6→295.5 for SK3541, and 520.3→99.1 for SK3304 (internal standard). The assay utilized a single liquid–liquid extraction and isocratic elution, and the LLOQ was 1ng/ml using 0.2ml human plasma. The assay was linear over a range from 1 to 1000ng/ml for both SK3530 and SK3541, with correlation coefficients >0.9999. The mean intra- and inter-day assay accuracy ranged from 94.7 to 101.6% and 96.8 to 101.1% for SK3530 and 92.6–105.7% and 97.4–107.8% for SK3541, respectively. The mean intra- and inter-day precision was between 7.2–12.1% and 5.7–7.4% for SK3530 and 4.6–13.2% and 5.0–14.1% for SK3541, respectively. The developed assay was applied to a clinical pharmacokinetic study after oral administration of SK3530 in healthy male volunteers (dose 100mg).</description><subject>Administration, Oral</subject><subject>Adult</subject><subject>Analysis</subject><subject>Analytical, structural and metabolic biochemistry</subject><subject>Biological and medical sciences</subject><subject>Calibration</subject><subject>Chromatography, High Pressure Liquid</subject><subject>Erectile Dysfunction - drug therapy</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>General pharmacology</subject><subject>Humans</subject><subject>LC/MS/MS</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Molecular Structure</subject><subject>PDE-5 inhibitor</subject><subject>Pharmacokinetics</subject><subject>Pharmacology, Clinical - methods</subject><subject>Pharmacology. Drug treatments</subject><subject>Pyrimidinones - blood</subject><subject>Pyrimidinones - pharmacokinetics</subject><subject>Pyrimidinones - therapeutic use</subject><subject>Quality Control</subject><subject>Reference Standards</subject><subject>Reproducibility of Results</subject><subject>Sensitivity and Specificity</subject><subject>SK3530</subject><subject>SK3541</subject><subject>Spectrometry, Mass, Electrospray Ionization</subject><subject>Sulfones - blood</subject><subject>Sulfones - pharmacokinetics</subject><subject>Sulfones - therapeutic use</subject><subject>Tandem Mass Spectrometry</subject><issn>0731-7085</issn><issn>1873-264X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2007</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kVtrFTEUhQdR7LH6B3yQvCgtNKfJZC6Z4oscr1jxoQpCKSGTCyfHTBKTmeIo_nGfzLlA34SQkMW3F3vvVRRPMVpihJvzzXITer4sEWqXqFmiEt8rFpi2BJZN9e1-sUAtwbBFtD4qHqW0QQjVuKseFke4bWhX4m5R_H2tbpX1YVBuBF6Dy9X5p6t8AE-Jz0D7CMa1AlKNKg7G8dF4t-VqqMb1bGEJf9fwuoInJVzPMvqf804_DSaoyH8ZpyCGabLau9neZDxEHzIV1ioLf2C7E7IROauhNDuPMMforb8mZyWUN_lnBiONgxX0ToGTq4-kJugUGAfW08AdCJangV8AHoI1Yt_i6AEHwhqXBQvCmseBC_899zMaAdI4yflx8UBzm9STw3tcfH375svqPbz8_O7D6tUlFIRWY75L2WoqesJFJxuqNeKt6Bve1ZXmGtNO9D2WHdG1lLTDXa0pqSuKSY-atuLkuHix982T_phUGtlgklDWcqf8lFhDy7armyqD5R4U0acUlWYhj87jzDBi28TZhm0TZ9vEGWpYTjwXPTu4T_2g5F3JIeIMPD8APOVd6MidMOmO6xBtq5Jk7uWeU3kXt0ZFloRRTihpohIjk978r49_idDNqQ</recordid><startdate>20070921</startdate><enddate>20070921</enddate><creator>Shin, Beom Soo</creator><creator>Hu, Seul Ki</creator><creator>Kim, John</creator><creator>Oh, Joon Gyo</creator><creator>Youn, Won-No</creator><creator>Lee, Bongyong</creator><creator>Um, Key An</creator><creator>Kim, Dae-Kee</creator><creator>Lee, Ju Young</creator><creator>Yoo, Sun Dong</creator><general>Elsevier B.V</general><general>Elsevier Science</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></search><sort><creationdate>20070921</creationdate><title>Development of LC/MS/MS assay for the determination of 5-ethyl-2-{5-[4-(2-hydroxyethyl)piperazine-1-sulfonyl]-2-propoxyphenyl}-7-propyl-3,5-dihydropyrrolo[3,2-d]pyrimidin-4-one (SK3530) in human plasma: application to a clinical pharmacokinetic study</title><author>Shin, Beom Soo ; Hu, Seul Ki ; Kim, John ; Oh, Joon Gyo ; Youn, Won-No ; Lee, Bongyong ; Um, Key An ; Kim, Dae-Kee ; Lee, Ju Young ; Yoo, Sun Dong</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c384t-c32d7f8cb3ac9d68ff0a7cb6a954faf189cbb1d93f5dd89195f8354813b0674a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2007</creationdate><topic>Administration, Oral</topic><topic>Adult</topic><topic>Analysis</topic><topic>Analytical, structural and metabolic biochemistry</topic><topic>Biological and medical sciences</topic><topic>Calibration</topic><topic>Chromatography, High Pressure Liquid</topic><topic>Erectile Dysfunction - drug therapy</topic><topic>Fundamental and applied biological sciences. Psychology</topic><topic>General pharmacology</topic><topic>Humans</topic><topic>LC/MS/MS</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Molecular Structure</topic><topic>PDE-5 inhibitor</topic><topic>Pharmacokinetics</topic><topic>Pharmacology, Clinical - methods</topic><topic>Pharmacology. Drug treatments</topic><topic>Pyrimidinones - blood</topic><topic>Pyrimidinones - pharmacokinetics</topic><topic>Pyrimidinones - therapeutic use</topic><topic>Quality Control</topic><topic>Reference Standards</topic><topic>Reproducibility of Results</topic><topic>Sensitivity and Specificity</topic><topic>SK3530</topic><topic>SK3541</topic><topic>Spectrometry, Mass, Electrospray Ionization</topic><topic>Sulfones - blood</topic><topic>Sulfones - pharmacokinetics</topic><topic>Sulfones - therapeutic use</topic><topic>Tandem Mass Spectrometry</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Shin, Beom Soo</creatorcontrib><creatorcontrib>Hu, Seul Ki</creatorcontrib><creatorcontrib>Kim, John</creatorcontrib><creatorcontrib>Oh, Joon Gyo</creatorcontrib><creatorcontrib>Youn, Won-No</creatorcontrib><creatorcontrib>Lee, Bongyong</creatorcontrib><creatorcontrib>Um, Key An</creatorcontrib><creatorcontrib>Kim, Dae-Kee</creatorcontrib><creatorcontrib>Lee, Ju Young</creatorcontrib><creatorcontrib>Yoo, Sun Dong</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><jtitle>Journal of pharmaceutical and biomedical analysis</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Shin, Beom Soo</au><au>Hu, Seul Ki</au><au>Kim, John</au><au>Oh, Joon Gyo</au><au>Youn, Won-No</au><au>Lee, Bongyong</au><au>Um, Key An</au><au>Kim, Dae-Kee</au><au>Lee, Ju Young</au><au>Yoo, Sun Dong</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Development of LC/MS/MS assay for the determination of 5-ethyl-2-{5-[4-(2-hydroxyethyl)piperazine-1-sulfonyl]-2-propoxyphenyl}-7-propyl-3,5-dihydropyrrolo[3,2-d]pyrimidin-4-one (SK3530) in human plasma: application to a clinical pharmacokinetic study</atitle><jtitle>Journal of pharmaceutical and biomedical analysis</jtitle><addtitle>J Pharm Biomed Anal</addtitle><date>2007-09-21</date><risdate>2007</risdate><volume>45</volume><issue>1</issue><spage>176</spage><epage>184</epage><pages>176-184</pages><issn>0731-7085</issn><eissn>1873-264X</eissn><coden>JPBADA</coden><abstract>5-Ethyl-2-{5-[4-(2-hydroxyethyl)piperazine-1-sulfonyl]-2-propoxyphenyl}-7-propyl-3,5-dihydropyrrolo[3,2-d]pyrimidin-4-one (SK3530) is a new phosphodiesterase type-5 inhibitor currently undergoing a Phase III investigation for the treatment of male erectile dysfunction. This study first describes a rapid and sensitive LC/MS/MS assay method for the quantification of SK3530 and its major metabolite, SK3541, in human plasma. The assay was validated to demonstrate the specificity, linearity, recovery, lower limit of quantification (LLOQ), accuracy, and precision. The multiple reaction monitoring was based on the transition of m/z=532.5→99.1 for SK3530, 488.6→295.5 for SK3541, and 520.3→99.1 for SK3304 (internal standard). The assay utilized a single liquid–liquid extraction and isocratic elution, and the LLOQ was 1ng/ml using 0.2ml human plasma. The assay was linear over a range from 1 to 1000ng/ml for both SK3530 and SK3541, with correlation coefficients >0.9999. The mean intra- and inter-day assay accuracy ranged from 94.7 to 101.6% and 96.8 to 101.1% for SK3530 and 92.6–105.7% and 97.4–107.8% for SK3541, respectively. The mean intra- and inter-day precision was between 7.2–12.1% and 5.7–7.4% for SK3530 and 4.6–13.2% and 5.0–14.1% for SK3541, respectively. The developed assay was applied to a clinical pharmacokinetic study after oral administration of SK3530 in healthy male volunteers (dose 100mg).</abstract><cop>Amsterdam</cop><pub>Elsevier B.V</pub><pmid>17689219</pmid><doi>10.1016/j.jpba.2007.06.021</doi><tpages>9</tpages></addata></record> |
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subjects | Administration, Oral Adult Analysis Analytical, structural and metabolic biochemistry Biological and medical sciences Calibration Chromatography, High Pressure Liquid Erectile Dysfunction - drug therapy Fundamental and applied biological sciences. Psychology General pharmacology Humans LC/MS/MS Male Medical sciences Molecular Structure PDE-5 inhibitor Pharmacokinetics Pharmacology, Clinical - methods Pharmacology. Drug treatments Pyrimidinones - blood Pyrimidinones - pharmacokinetics Pyrimidinones - therapeutic use Quality Control Reference Standards Reproducibility of Results Sensitivity and Specificity SK3530 SK3541 Spectrometry, Mass, Electrospray Ionization Sulfones - blood Sulfones - pharmacokinetics Sulfones - therapeutic use Tandem Mass Spectrometry |
title | Development of LC/MS/MS assay for the determination of 5-ethyl-2-{5-[4-(2-hydroxyethyl)piperazine-1-sulfonyl]-2-propoxyphenyl}-7-propyl-3,5-dihydropyrrolo[3,2-d]pyrimidin-4-one (SK3530) in human plasma: application to a clinical pharmacokinetic study |
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