Liquid chromatography–tandem mass spectrometry quantification of levosulpiride in human plasma and its application to bioequivalence study
An improved method for determining levels of levosulpiride in human plasma using ultra-performance liquid chromatography–tandem mass spectrometry (UPLC–MS/MS) was developed and validated. The protein precipitation method was used for plasma sample preparation. Levosulpiride and an internal standard...
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Veröffentlicht in: | Journal of chromatography. B, Analytical technologies in the biomedical and life sciences Analytical technologies in the biomedical and life sciences, 2010-08, Vol.878 (24), p.2280-2285 |
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container_title | Journal of chromatography. B, Analytical technologies in the biomedical and life sciences |
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creator | Phapale, Prasad B. Lee, Hae Won Lim, Mi-sun Seong, Sook Jin Kim, Eun-Hee Park, Jeonghyeon Lee, Miran Hwang, Sung-Kyu Yoon, Young-Ran |
description | An improved method for determining levels of levosulpiride in human plasma using ultra-performance liquid chromatography–tandem mass spectrometry (UPLC–MS/MS) was developed and validated. The protein precipitation method was used for plasma sample preparation. Levosulpiride and an internal standard (IS) were isocratically separated on a UPLC BEH C
18 column with a mobile phase of ammonium formate buffer (1
mM, adjusted to pH 3 with formic acid) and acetonitrile (60:40, v/v). MS/MS detection was performed by monitoring the parent
→
daughter pair of levosulpiride and the IS at
m/z 342
→
112 and 329
→
256, respectively. The method was linear from 2.5 to 200
ng/mL and exhibited acceptable precision and percent recovery. The method was successfully demonstrated in pharmacokinetic and bioequivalence studies of two levosulpiride oral formulations administered to healthy volunteers. When compared to the previous LC–MS methods, the proposed method is faster, well-validated, and uses lesser plasma volume and a similar sensitivity. The use of UPLC allowed rapid and sensitive quantification of levosulpiride, making this method suitable for high-throughput clinical applications. |
doi_str_mv | 10.1016/j.jchromb.2010.06.036 |
format | Article |
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18 column with a mobile phase of ammonium formate buffer (1
mM, adjusted to pH 3 with formic acid) and acetonitrile (60:40, v/v). MS/MS detection was performed by monitoring the parent
→
daughter pair of levosulpiride and the IS at
m/z 342
→
112 and 329
→
256, respectively. The method was linear from 2.5 to 200
ng/mL and exhibited acceptable precision and percent recovery. The method was successfully demonstrated in pharmacokinetic and bioequivalence studies of two levosulpiride oral formulations administered to healthy volunteers. When compared to the previous LC–MS methods, the proposed method is faster, well-validated, and uses lesser plasma volume and a similar sensitivity. The use of UPLC allowed rapid and sensitive quantification of levosulpiride, making this method suitable for high-throughput clinical applications.</description><identifier>ISSN: 1570-0232</identifier><identifier>EISSN: 1873-376X</identifier><identifier>DOI: 10.1016/j.jchromb.2010.06.036</identifier><identifier>PMID: 20656570</identifier><language>eng</language><publisher>Amsterdam: Elsevier B.V</publisher><subject>Acetonitrile ; Adult ; Analysis ; Analytical, structural and metabolic biochemistry ; Bioanalytical method validation ; Biological and medical sciences ; Chromatography ; Chromatography, High Pressure Liquid - methods ; Formates ; Formic acid ; Fundamental and applied biological sciences. Psychology ; General pharmacology ; Human ; Human plasma ; Humans ; Levosulpiride ; Liquids ; Male ; Mass spectrometry ; Medical sciences ; Parents ; Pharmacokinetic study ; Pharmacology. Drug treatments ; Reproducibility of Results ; Sensitivity and Specificity ; Sulpiride - analogs & derivatives ; Sulpiride - blood ; Sulpiride - pharmacokinetics ; Tandem Mass Spectrometry - methods ; Therapeutic Equivalency ; Tiapamil Hydrochloride - analysis ; UPLC–MS/MS</subject><ispartof>Journal of chromatography. B, Analytical technologies in the biomedical and life sciences, 2010-08, Vol.878 (24), p.2280-2285</ispartof><rights>2010 Elsevier B.V.</rights><rights>2015 INIST-CNRS</rights><rights>Copyright 2010 Elsevier B.V. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c521t-9d8459ba6cb32ed6116ea9a3aa6bf1a16c3e625cdfa14f474be4261475503e6e3</citedby><cites>FETCH-LOGICAL-c521t-9d8459ba6cb32ed6116ea9a3aa6bf1a16c3e625cdfa14f474be4261475503e6e3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.jchromb.2010.06.036$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=23110821$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20656570$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Phapale, Prasad B.</creatorcontrib><creatorcontrib>Lee, Hae Won</creatorcontrib><creatorcontrib>Lim, Mi-sun</creatorcontrib><creatorcontrib>Seong, Sook Jin</creatorcontrib><creatorcontrib>Kim, Eun-Hee</creatorcontrib><creatorcontrib>Park, Jeonghyeon</creatorcontrib><creatorcontrib>Lee, Miran</creatorcontrib><creatorcontrib>Hwang, Sung-Kyu</creatorcontrib><creatorcontrib>Yoon, Young-Ran</creatorcontrib><title>Liquid chromatography–tandem mass spectrometry quantification of levosulpiride in human plasma and its application to bioequivalence study</title><title>Journal of chromatography. B, Analytical technologies in the biomedical and life sciences</title><addtitle>J Chromatogr B Analyt Technol Biomed Life Sci</addtitle><description>An improved method for determining levels of levosulpiride in human plasma using ultra-performance liquid chromatography–tandem mass spectrometry (UPLC–MS/MS) was developed and validated. The protein precipitation method was used for plasma sample preparation. Levosulpiride and an internal standard (IS) were isocratically separated on a UPLC BEH C
18 column with a mobile phase of ammonium formate buffer (1
mM, adjusted to pH 3 with formic acid) and acetonitrile (60:40, v/v). MS/MS detection was performed by monitoring the parent
→
daughter pair of levosulpiride and the IS at
m/z 342
→
112 and 329
→
256, respectively. The method was linear from 2.5 to 200
ng/mL and exhibited acceptable precision and percent recovery. The method was successfully demonstrated in pharmacokinetic and bioequivalence studies of two levosulpiride oral formulations administered to healthy volunteers. When compared to the previous LC–MS methods, the proposed method is faster, well-validated, and uses lesser plasma volume and a similar sensitivity. The use of UPLC allowed rapid and sensitive quantification of levosulpiride, making this method suitable for high-throughput clinical applications.</description><subject>Acetonitrile</subject><subject>Adult</subject><subject>Analysis</subject><subject>Analytical, structural and metabolic biochemistry</subject><subject>Bioanalytical method validation</subject><subject>Biological and medical sciences</subject><subject>Chromatography</subject><subject>Chromatography, High Pressure Liquid - methods</subject><subject>Formates</subject><subject>Formic acid</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>General pharmacology</subject><subject>Human</subject><subject>Human plasma</subject><subject>Humans</subject><subject>Levosulpiride</subject><subject>Liquids</subject><subject>Male</subject><subject>Mass spectrometry</subject><subject>Medical sciences</subject><subject>Parents</subject><subject>Pharmacokinetic study</subject><subject>Pharmacology. Drug treatments</subject><subject>Reproducibility of Results</subject><subject>Sensitivity and Specificity</subject><subject>Sulpiride - analogs & derivatives</subject><subject>Sulpiride - blood</subject><subject>Sulpiride - pharmacokinetics</subject><subject>Tandem Mass Spectrometry - methods</subject><subject>Therapeutic Equivalency</subject><subject>Tiapamil Hydrochloride - analysis</subject><subject>UPLC–MS/MS</subject><issn>1570-0232</issn><issn>1873-376X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkc2O0zAUhSMEYoaBRwB5g1il-Ce20xVCI_6kSmxAYmfd2DfUVRKntlOpOx6AHW_Ik-DSDixnZcvnO-da91TVc0ZXjDL1erfa2W0MY7fitLxRtaJCPaiuWatFLbT69rDcpaY15YJfVU9S2lHKNNXicXXFqZKqiNfVz43fL96Rv1mQw_cI8_b4-8evDJPDkYyQEkkz2lx0zPFI9gtM2ffeQvZhIqEnAx5CWobZR--Q-IlslxEmMg-QRiAlh_icCMzzcGfKgXQ-YJl8gAEniyTlxR2fVo96GBI-u5w31df3777cfqw3nz98un27qa3kLNdr1zZy3YGyneDoFGMKYQ0CQHU9A6asQMWldT2wpm9002HDFWu0lLQoKG6qV-fcOYb9gimb0SeLwwAThiUZ3WquGk3F_WTTruVaCl5IeSZtDClF7M0c_QjxaBg1p8bMzlwaM6fGDFWmNFZ8Ly4Tlm5E9891V1EBXl4ASBaGPsJkffrPCcZoy1nh3pw5LJs7eIwmWX_arfOx1Gdc8Pd85Q_aFrxH</recordid><startdate>20100815</startdate><enddate>20100815</enddate><creator>Phapale, Prasad B.</creator><creator>Lee, Hae Won</creator><creator>Lim, Mi-sun</creator><creator>Seong, Sook Jin</creator><creator>Kim, Eun-Hee</creator><creator>Park, Jeonghyeon</creator><creator>Lee, Miran</creator><creator>Hwang, Sung-Kyu</creator><creator>Yoon, Young-Ran</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>7TB</scope><scope>8FD</scope><scope>FR3</scope></search><sort><creationdate>20100815</creationdate><title>Liquid chromatography–tandem mass spectrometry quantification of levosulpiride in human plasma and its application to bioequivalence study</title><author>Phapale, Prasad B. ; Lee, Hae Won ; Lim, Mi-sun ; Seong, Sook Jin ; Kim, Eun-Hee ; Park, Jeonghyeon ; Lee, Miran ; Hwang, Sung-Kyu ; Yoon, Young-Ran</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c521t-9d8459ba6cb32ed6116ea9a3aa6bf1a16c3e625cdfa14f474be4261475503e6e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Acetonitrile</topic><topic>Adult</topic><topic>Analysis</topic><topic>Analytical, structural and metabolic biochemistry</topic><topic>Bioanalytical method validation</topic><topic>Biological and medical sciences</topic><topic>Chromatography</topic><topic>Chromatography, High Pressure Liquid - methods</topic><topic>Formates</topic><topic>Formic acid</topic><topic>Fundamental and applied biological sciences. Psychology</topic><topic>General pharmacology</topic><topic>Human</topic><topic>Human plasma</topic><topic>Humans</topic><topic>Levosulpiride</topic><topic>Liquids</topic><topic>Male</topic><topic>Mass spectrometry</topic><topic>Medical sciences</topic><topic>Parents</topic><topic>Pharmacokinetic study</topic><topic>Pharmacology. Drug treatments</topic><topic>Reproducibility of Results</topic><topic>Sensitivity and Specificity</topic><topic>Sulpiride - analogs & derivatives</topic><topic>Sulpiride - blood</topic><topic>Sulpiride - pharmacokinetics</topic><topic>Tandem Mass Spectrometry - methods</topic><topic>Therapeutic Equivalency</topic><topic>Tiapamil Hydrochloride - analysis</topic><topic>UPLC–MS/MS</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Phapale, Prasad B.</creatorcontrib><creatorcontrib>Lee, Hae Won</creatorcontrib><creatorcontrib>Lim, Mi-sun</creatorcontrib><creatorcontrib>Seong, Sook Jin</creatorcontrib><creatorcontrib>Kim, Eun-Hee</creatorcontrib><creatorcontrib>Park, Jeonghyeon</creatorcontrib><creatorcontrib>Lee, Miran</creatorcontrib><creatorcontrib>Hwang, Sung-Kyu</creatorcontrib><creatorcontrib>Yoon, Young-Ran</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>Mechanical & Transportation Engineering Abstracts</collection><collection>Technology Research Database</collection><collection>Engineering Research Database</collection><jtitle>Journal of chromatography. B, Analytical technologies in the biomedical and life sciences</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Phapale, Prasad B.</au><au>Lee, Hae Won</au><au>Lim, Mi-sun</au><au>Seong, Sook Jin</au><au>Kim, Eun-Hee</au><au>Park, Jeonghyeon</au><au>Lee, Miran</au><au>Hwang, Sung-Kyu</au><au>Yoon, Young-Ran</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Liquid chromatography–tandem mass spectrometry quantification of levosulpiride in human plasma and its application to bioequivalence study</atitle><jtitle>Journal of chromatography. B, Analytical technologies in the biomedical and life sciences</jtitle><addtitle>J Chromatogr B Analyt Technol Biomed Life Sci</addtitle><date>2010-08-15</date><risdate>2010</risdate><volume>878</volume><issue>24</issue><spage>2280</spage><epage>2285</epage><pages>2280-2285</pages><issn>1570-0232</issn><eissn>1873-376X</eissn><abstract>An improved method for determining levels of levosulpiride in human plasma using ultra-performance liquid chromatography–tandem mass spectrometry (UPLC–MS/MS) was developed and validated. The protein precipitation method was used for plasma sample preparation. Levosulpiride and an internal standard (IS) were isocratically separated on a UPLC BEH C
18 column with a mobile phase of ammonium formate buffer (1
mM, adjusted to pH 3 with formic acid) and acetonitrile (60:40, v/v). MS/MS detection was performed by monitoring the parent
→
daughter pair of levosulpiride and the IS at
m/z 342
→
112 and 329
→
256, respectively. The method was linear from 2.5 to 200
ng/mL and exhibited acceptable precision and percent recovery. The method was successfully demonstrated in pharmacokinetic and bioequivalence studies of two levosulpiride oral formulations administered to healthy volunteers. When compared to the previous LC–MS methods, the proposed method is faster, well-validated, and uses lesser plasma volume and a similar sensitivity. The use of UPLC allowed rapid and sensitive quantification of levosulpiride, making this method suitable for high-throughput clinical applications.</abstract><cop>Amsterdam</cop><pub>Elsevier B.V</pub><pmid>20656570</pmid><doi>10.1016/j.jchromb.2010.06.036</doi><tpages>6</tpages></addata></record> |
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subjects | Acetonitrile Adult Analysis Analytical, structural and metabolic biochemistry Bioanalytical method validation Biological and medical sciences Chromatography Chromatography, High Pressure Liquid - methods Formates Formic acid Fundamental and applied biological sciences. Psychology General pharmacology Human Human plasma Humans Levosulpiride Liquids Male Mass spectrometry Medical sciences Parents Pharmacokinetic study Pharmacology. Drug treatments Reproducibility of Results Sensitivity and Specificity Sulpiride - analogs & derivatives Sulpiride - blood Sulpiride - pharmacokinetics Tandem Mass Spectrometry - methods Therapeutic Equivalency Tiapamil Hydrochloride - analysis UPLC–MS/MS |
title | Liquid chromatography–tandem mass spectrometry quantification of levosulpiride in human plasma and its application to bioequivalence study |
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