Simultaneous determination of metoprolol succinate and amlodipine besylate in human plasma by liquid chromatography–tandem mass spectrometry method and its application in bioequivalence study
A simple, sensitive and specific liquid chromatography–tandem mass spectrometry method was developed and validated for quantification of metoprolol succinate (MPS) and amlodipine besylate (AM) using hydrochlorothiazide (HCTZ) as IS in human plasma. Both the drugs were extracted by simple liquid–liqu...
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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, 2008-09, Vol.873 (1), p.77-85 |
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container_title | Journal of chromatography. B, Analytical technologies in the biomedical and life sciences |
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creator | Sarkar, Amlan Kanti Ghosh, Debotri Das, Ayan Selvan, P. Senthamil Gowda, K. Veeran Mandal, Uttam Bose, Anirbandeep Agarwal, Sangeeta Bhaumik, Uttam Pal, Tapan Kumar |
description | A simple, sensitive and specific liquid chromatography–tandem mass spectrometry method was developed and validated for quantification of metoprolol succinate (MPS) and amlodipine besylate (AM) using hydrochlorothiazide (HCTZ) as IS in human plasma. Both the drugs were extracted by simple liquid–liquid extraction with chloroform. The chromatographic separation was performed on a reversed-phase peerless basic C18 column with a mobile phase of methanol–water containing 0.5% formic acid (8:2, v/v). The protonated analyte was quantitated in positive ionization by multiple reaction monitoring with a mass spectrometer. The method was validated over the concentration range of 1–100
ng/ml for MPS and 1–15
ng/ml AM in human plasma. The MRM transition of
m/
z 268.10–103.10,
m/
z 409.10–334.20 and
m/
z 296.00–205.10 were used to measure MPS, AM and HCTZ (IS), respectively. This method was successfully applied to the pharmacokinetic study of fixed dose combination (FDC) of MPS and AM formulation product after an oral administration to Indian healthy human volunteers. |
doi_str_mv | 10.1016/j.jchromb.2008.07.040 |
format | Article |
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ng/ml for MPS and 1–15
ng/ml AM in human plasma. The MRM transition of
m/
z 268.10–103.10,
m/
z 409.10–334.20 and
m/
z 296.00–205.10 were used to measure MPS, AM and HCTZ (IS), respectively. This method was successfully applied to the pharmacokinetic study of fixed dose combination (FDC) of MPS and AM formulation product after an oral administration to Indian healthy human volunteers.</description><identifier>ISSN: 1570-0232</identifier><identifier>EISSN: 1873-376X</identifier><identifier>DOI: 10.1016/j.jchromb.2008.07.040</identifier><identifier>PMID: 18760977</identifier><language>eng</language><publisher>Amsterdam: Elsevier B.V</publisher><subject>Amlodipine - blood ; Amlodipine - pharmacokinetics ; Amlodipine besylate ; Analysis ; Analytical, structural and metabolic biochemistry ; Biological and medical sciences ; Chromatography, Liquid - methods ; Drug Stability ; Fundamental and applied biological sciences. Psychology ; General pharmacology ; Hydrochlorothiazide ; LC–MS/MS ; Medical sciences ; Metoprolol - analogs & derivatives ; Metoprolol - blood ; Metoprolol - pharmacokinetics ; Metoprolol succinate ; Pharmacology. Drug treatments ; Reproducibility of Results ; Sensitivity and Specificity ; Tandem Mass Spectrometry - methods ; Therapeutic Equivalency ; Uncertainty ; Validation</subject><ispartof>Journal of chromatography. B, Analytical technologies in the biomedical and life sciences, 2008-09, Vol.873 (1), p.77-85</ispartof><rights>2008 Elsevier B.V.</rights><rights>2008 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c422t-1342657caecebdb7633f5c766853dfd6f4a96a8fb9de9d6e9face426a0868cdf3</citedby><cites>FETCH-LOGICAL-c422t-1342657caecebdb7633f5c766853dfd6f4a96a8fb9de9d6e9face426a0868cdf3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S1570023208005795$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=20687785$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/18760977$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Sarkar, Amlan Kanti</creatorcontrib><creatorcontrib>Ghosh, Debotri</creatorcontrib><creatorcontrib>Das, Ayan</creatorcontrib><creatorcontrib>Selvan, P. Senthamil</creatorcontrib><creatorcontrib>Gowda, K. Veeran</creatorcontrib><creatorcontrib>Mandal, Uttam</creatorcontrib><creatorcontrib>Bose, Anirbandeep</creatorcontrib><creatorcontrib>Agarwal, Sangeeta</creatorcontrib><creatorcontrib>Bhaumik, Uttam</creatorcontrib><creatorcontrib>Pal, Tapan Kumar</creatorcontrib><title>Simultaneous determination of metoprolol succinate and amlodipine besylate in human plasma by liquid chromatography–tandem mass spectrometry method and its application in 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>A simple, sensitive and specific liquid chromatography–tandem mass spectrometry method was developed and validated for quantification of metoprolol succinate (MPS) and amlodipine besylate (AM) using hydrochlorothiazide (HCTZ) as IS in human plasma. Both the drugs were extracted by simple liquid–liquid extraction with chloroform. The chromatographic separation was performed on a reversed-phase peerless basic C18 column with a mobile phase of methanol–water containing 0.5% formic acid (8:2, v/v). The protonated analyte was quantitated in positive ionization by multiple reaction monitoring with a mass spectrometer. The method was validated over the concentration range of 1–100
ng/ml for MPS and 1–15
ng/ml AM in human plasma. The MRM transition of
m/
z 268.10–103.10,
m/
z 409.10–334.20 and
m/
z 296.00–205.10 were used to measure MPS, AM and HCTZ (IS), respectively. This method was successfully applied to the pharmacokinetic study of fixed dose combination (FDC) of MPS and AM formulation product after an oral administration to Indian healthy human volunteers.</description><subject>Amlodipine - blood</subject><subject>Amlodipine - pharmacokinetics</subject><subject>Amlodipine besylate</subject><subject>Analysis</subject><subject>Analytical, structural and metabolic biochemistry</subject><subject>Biological and medical sciences</subject><subject>Chromatography, Liquid - methods</subject><subject>Drug Stability</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>General pharmacology</subject><subject>Hydrochlorothiazide</subject><subject>LC–MS/MS</subject><subject>Medical sciences</subject><subject>Metoprolol - analogs & derivatives</subject><subject>Metoprolol - blood</subject><subject>Metoprolol - pharmacokinetics</subject><subject>Metoprolol succinate</subject><subject>Pharmacology. Drug treatments</subject><subject>Reproducibility of Results</subject><subject>Sensitivity and Specificity</subject><subject>Tandem Mass Spectrometry - methods</subject><subject>Therapeutic Equivalency</subject><subject>Uncertainty</subject><subject>Validation</subject><issn>1570-0232</issn><issn>1873-376X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2008</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkU2O1DAQhSMEYoaGI4C8gV2C82cnK4RGw480EgtAYmdV7Artlh1nbGek7LgDJ-IqnARn0oIlK1uur-qV38uy5yUtSlqy16fiJI_e2aGoKO0Kygva0AfZZdnxOq85-_Yw3VtOc1rV1UX2JIQTpSWnvH6cXSSI0Z7zy-zXZ20XE2FCtwSiMKK3eoKo3UTcSCxGN3tnnCFhkXKrIIFJEbDGKT3rCcmAYTXbu57IcbEwkdlAsECGlRh9u2hF7jeF6L57mI_r7x8_k6BCSyyEQMKMMqY6Rr9ugken7iV0DATm2Wi5r5PGD9phGngHBieJJMRFrU-zRyOYgM_O5yH7-u76y9WH_ObT-49Xb29y2VRVzMu6qVjLJaDEQQ2c1fXYSs5Y19ZqVGxsoGfQjUOvsFcM-xEkphagHeukGutD9mqfm_y4XTBEYXWQaMzunWB9WzV9xxLY7qD0LgSPo5i9tuBXUVKxZSdO4pyd2LITlIuUXep7cRZYBovqX9c5rAS8PAMQJJjRwyR1-MtVlHWcp-8csjc7h8mOO41eBKk3w5T2yWqhnP7PKn8A70LECg</recordid><startdate>20080915</startdate><enddate>20080915</enddate><creator>Sarkar, Amlan Kanti</creator><creator>Ghosh, Debotri</creator><creator>Das, Ayan</creator><creator>Selvan, P. Senthamil</creator><creator>Gowda, K. Veeran</creator><creator>Mandal, Uttam</creator><creator>Bose, Anirbandeep</creator><creator>Agarwal, Sangeeta</creator><creator>Bhaumik, Uttam</creator><creator>Pal, Tapan Kumar</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>20080915</creationdate><title>Simultaneous determination of metoprolol succinate and amlodipine besylate in human plasma by liquid chromatography–tandem mass spectrometry method and its application in bioequivalence study</title><author>Sarkar, Amlan Kanti ; Ghosh, Debotri ; Das, Ayan ; Selvan, P. Senthamil ; Gowda, K. Veeran ; Mandal, Uttam ; Bose, Anirbandeep ; Agarwal, Sangeeta ; Bhaumik, Uttam ; Pal, Tapan Kumar</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c422t-1342657caecebdb7633f5c766853dfd6f4a96a8fb9de9d6e9face426a0868cdf3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2008</creationdate><topic>Amlodipine - blood</topic><topic>Amlodipine - pharmacokinetics</topic><topic>Amlodipine besylate</topic><topic>Analysis</topic><topic>Analytical, structural and metabolic biochemistry</topic><topic>Biological and medical sciences</topic><topic>Chromatography, Liquid - methods</topic><topic>Drug Stability</topic><topic>Fundamental and applied biological sciences. Psychology</topic><topic>General pharmacology</topic><topic>Hydrochlorothiazide</topic><topic>LC–MS/MS</topic><topic>Medical sciences</topic><topic>Metoprolol - analogs & derivatives</topic><topic>Metoprolol - blood</topic><topic>Metoprolol - pharmacokinetics</topic><topic>Metoprolol succinate</topic><topic>Pharmacology. Drug treatments</topic><topic>Reproducibility of Results</topic><topic>Sensitivity and Specificity</topic><topic>Tandem Mass Spectrometry - methods</topic><topic>Therapeutic Equivalency</topic><topic>Uncertainty</topic><topic>Validation</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Sarkar, Amlan Kanti</creatorcontrib><creatorcontrib>Ghosh, Debotri</creatorcontrib><creatorcontrib>Das, Ayan</creatorcontrib><creatorcontrib>Selvan, P. Senthamil</creatorcontrib><creatorcontrib>Gowda, K. Veeran</creatorcontrib><creatorcontrib>Mandal, Uttam</creatorcontrib><creatorcontrib>Bose, Anirbandeep</creatorcontrib><creatorcontrib>Agarwal, Sangeeta</creatorcontrib><creatorcontrib>Bhaumik, Uttam</creatorcontrib><creatorcontrib>Pal, Tapan Kumar</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 chromatography. B, Analytical technologies in the biomedical and life sciences</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Sarkar, Amlan Kanti</au><au>Ghosh, Debotri</au><au>Das, Ayan</au><au>Selvan, P. Senthamil</au><au>Gowda, K. Veeran</au><au>Mandal, Uttam</au><au>Bose, Anirbandeep</au><au>Agarwal, Sangeeta</au><au>Bhaumik, Uttam</au><au>Pal, Tapan Kumar</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Simultaneous determination of metoprolol succinate and amlodipine besylate in human plasma by liquid chromatography–tandem mass spectrometry method and its application in 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>2008-09-15</date><risdate>2008</risdate><volume>873</volume><issue>1</issue><spage>77</spage><epage>85</epage><pages>77-85</pages><issn>1570-0232</issn><eissn>1873-376X</eissn><abstract>A simple, sensitive and specific liquid chromatography–tandem mass spectrometry method was developed and validated for quantification of metoprolol succinate (MPS) and amlodipine besylate (AM) using hydrochlorothiazide (HCTZ) as IS in human plasma. Both the drugs were extracted by simple liquid–liquid extraction with chloroform. The chromatographic separation was performed on a reversed-phase peerless basic C18 column with a mobile phase of methanol–water containing 0.5% formic acid (8:2, v/v). The protonated analyte was quantitated in positive ionization by multiple reaction monitoring with a mass spectrometer. The method was validated over the concentration range of 1–100
ng/ml for MPS and 1–15
ng/ml AM in human plasma. The MRM transition of
m/
z 268.10–103.10,
m/
z 409.10–334.20 and
m/
z 296.00–205.10 were used to measure MPS, AM and HCTZ (IS), respectively. This method was successfully applied to the pharmacokinetic study of fixed dose combination (FDC) of MPS and AM formulation product after an oral administration to Indian healthy human volunteers.</abstract><cop>Amsterdam</cop><pub>Elsevier B.V</pub><pmid>18760977</pmid><doi>10.1016/j.jchromb.2008.07.040</doi><tpages>9</tpages></addata></record> |
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subjects | Amlodipine - blood Amlodipine - pharmacokinetics Amlodipine besylate Analysis Analytical, structural and metabolic biochemistry Biological and medical sciences Chromatography, Liquid - methods Drug Stability Fundamental and applied biological sciences. Psychology General pharmacology Hydrochlorothiazide LC–MS/MS Medical sciences Metoprolol - analogs & derivatives Metoprolol - blood Metoprolol - pharmacokinetics Metoprolol succinate Pharmacology. Drug treatments Reproducibility of Results Sensitivity and Specificity Tandem Mass Spectrometry - methods Therapeutic Equivalency Uncertainty Validation |
title | Simultaneous determination of metoprolol succinate and amlodipine besylate in human plasma by liquid chromatography–tandem mass spectrometry method and its application in bioequivalence study |
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