Rapid determination of ambrisentan enantiomers by enantioselective liquid chromatography using cellulose-based chiral stationary phase in reverse phase mode
A sensitive, specific, and rapid high‐performance liquid chromatography (HPLC) method for the determination of ambrisentan enantiomers has been developed and validated. Six chiral columns were tested in a reversed‐phase system. Excellent enantioseparation with the resolution more than 2.5 was achiev...
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| Veröffentlicht in: | Journal of separation science 2012-04, Vol.35 (7), p.798-803 |
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| creator | Douša, Michal Gibala, Petr |
| description | A sensitive, specific, and rapid high‐performance liquid chromatography (HPLC) method for the determination of ambrisentan enantiomers has been developed and validated. Six chiral columns were tested in a reversed‐phase system. Excellent enantioseparation with the resolution more than 2.5 was achieved on Chiralcel OZ‐3R (cellulose 3‐chloro‐4‐methylphenylcarbamate) using mixture of 20 mM sodium formate (pH 3.0) with acetonitrile (55:45; v/v). Validation of the HPLC method including linearity, limit of detection, limit of quantification, precision, accuracy, and selectivity was performed according to the International Conference on Harmonisation (ICH) guidelines. The method has an advantage of a very quick chromatographic separation (less than 6 min) and therefore is highly suitable for routine determination of (R)‐ambrisentan in enantiopure active pharmaceutical ingredient (S)‐ambrisentan. |
| doi_str_mv | 10.1002/jssc.201101062 |
| format | Article |
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Six chiral columns were tested in a reversed‐phase system. Excellent enantioseparation with the resolution more than 2.5 was achieved on Chiralcel OZ‐3R (cellulose 3‐chloro‐4‐methylphenylcarbamate) using mixture of 20 mM sodium formate (pH 3.0) with acetonitrile (55:45; v/v). Validation of the HPLC method including linearity, limit of detection, limit of quantification, precision, accuracy, and selectivity was performed according to the International Conference on Harmonisation (ICH) guidelines. The method has an advantage of a very quick chromatographic separation (less than 6 min) and therefore is highly suitable for routine determination of (R)‐ambrisentan in enantiopure active pharmaceutical ingredient (S)‐ambrisentan.</description><identifier>ISSN: 1615-9306</identifier><identifier>EISSN: 1615-9314</identifier><identifier>DOI: 10.1002/jssc.201101062</identifier><identifier>PMID: 22532347</identifier><language>eng</language><publisher>Weinheim: Blackwell Publishing Ltd</publisher><subject>Acetonitrile ; Adsorption ; Ambrisentan ; Analysis ; Biological and medical sciences ; Cellulose - chemistry ; Chiral separation ; Chromatography ; Chromatography, High Pressure Liquid - instrumentation ; Chromatography, High Pressure Liquid - methods ; Chromatography, Reverse-Phase - instrumentation ; Chromatography, Reverse-Phase - methods ; Conferences ; Enantiomers ; Enantioselective chromatography ; General pharmacology ; Guidelines ; Liquid chromatography ; Medical sciences ; Pharmacology. Drug treatments ; Phenylpropionates - chemistry ; Pyridazines - chemistry ; Separation ; Sodium ; Stereoisomerism</subject><ispartof>Journal of separation science, 2012-04, Vol.35 (7), p.798-803</ispartof><rights>2012 WILEY‐VCH Verlag GmbH & Co. KGaA, Weinheim</rights><rights>2015 INIST-CNRS</rights><rights>2012 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4410-72ceb8ad5f5240a0eac2505bd8ddcf65220751c2f641d036f66d62bdbe84360e3</citedby><cites>FETCH-LOGICAL-c4410-72ceb8ad5f5240a0eac2505bd8ddcf65220751c2f641d036f66d62bdbe84360e3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fjssc.201101062$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fjssc.201101062$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=25802701$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22532347$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Douša, Michal</creatorcontrib><creatorcontrib>Gibala, Petr</creatorcontrib><title>Rapid determination of ambrisentan enantiomers by enantioselective liquid chromatography using cellulose-based chiral stationary phase in reverse phase mode</title><title>Journal of separation science</title><addtitle>J. Sep. Science</addtitle><description>A sensitive, specific, and rapid high‐performance liquid chromatography (HPLC) method for the determination of ambrisentan enantiomers has been developed and validated. Six chiral columns were tested in a reversed‐phase system. Excellent enantioseparation with the resolution more than 2.5 was achieved on Chiralcel OZ‐3R (cellulose 3‐chloro‐4‐methylphenylcarbamate) using mixture of 20 mM sodium formate (pH 3.0) with acetonitrile (55:45; v/v). Validation of the HPLC method including linearity, limit of detection, limit of quantification, precision, accuracy, and selectivity was performed according to the International Conference on Harmonisation (ICH) guidelines. The method has an advantage of a very quick chromatographic separation (less than 6 min) and therefore is highly suitable for routine determination of (R)‐ambrisentan in enantiopure active pharmaceutical ingredient (S)‐ambrisentan.</description><subject>Acetonitrile</subject><subject>Adsorption</subject><subject>Ambrisentan</subject><subject>Analysis</subject><subject>Biological and medical sciences</subject><subject>Cellulose - chemistry</subject><subject>Chiral separation</subject><subject>Chromatography</subject><subject>Chromatography, High Pressure Liquid - instrumentation</subject><subject>Chromatography, High Pressure Liquid - methods</subject><subject>Chromatography, Reverse-Phase - instrumentation</subject><subject>Chromatography, Reverse-Phase - methods</subject><subject>Conferences</subject><subject>Enantiomers</subject><subject>Enantioselective chromatography</subject><subject>General pharmacology</subject><subject>Guidelines</subject><subject>Liquid chromatography</subject><subject>Medical sciences</subject><subject>Pharmacology. Drug treatments</subject><subject>Phenylpropionates - chemistry</subject><subject>Pyridazines - chemistry</subject><subject>Separation</subject><subject>Sodium</subject><subject>Stereoisomerism</subject><issn>1615-9306</issn><issn>1615-9314</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkctu1DAUhiMEohfYskTeILHJcGzHTmaJBihUVVEp0KXl2Ccdl8RJ7aRl3oWHxWGmwxJWto-__9z-LHtBYUEB2JubGM2CAaVAQbJH2SGVVORLTovH-zvIg-woxhsAWlZLeJodMCY440V5mP36ogdnicURQ-e8Hl3vSd8Q3dXBRfSj9gS99ineYYik3jw8I7ZoRneHpHW3U8ph1qHv9NhfBz2sN2SKzl8Tg207tQnOax1xhlzQLYnjn0o6bMiwTh_EeRLwLlXAXaDrLT7LnjS6jfh8dx5n3z68_7r6mJ99Pvm0enuWm6KgkJfMYF1pKxrBCtCA2jABoraVtaaRgjEoBTWskQW1wGUjpZWstjVWBZeA_Dh7vc07hP52wjiqzsW5c-2xn6KiwCsOLO3uP1BYVjTtlid0sUVN6GMM2KghuC6NnKCZY2o2T-3NS4KXu9xT3aHd4w9uJeDVDtDR6LYJ2hsX_3KiAlYCTVyx5e5di5t_lFWnl5crVrJ5tnwrc3HEn3uZDj-ULHkp1NX5ibr6Ttnpu_MLdcF_A2Kpxak</recordid><startdate>201204</startdate><enddate>201204</enddate><creator>Douša, Michal</creator><creator>Gibala, Petr</creator><general>Blackwell Publishing Ltd</general><general>Wiley</general><scope>BSCLL</scope><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>7U5</scope><scope>8FD</scope><scope>L7M</scope></search><sort><creationdate>201204</creationdate><title>Rapid determination of ambrisentan enantiomers by enantioselective liquid chromatography using cellulose-based chiral stationary phase in reverse phase mode</title><author>Douša, Michal ; Gibala, Petr</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4410-72ceb8ad5f5240a0eac2505bd8ddcf65220751c2f641d036f66d62bdbe84360e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Acetonitrile</topic><topic>Adsorption</topic><topic>Ambrisentan</topic><topic>Analysis</topic><topic>Biological and medical sciences</topic><topic>Cellulose - chemistry</topic><topic>Chiral separation</topic><topic>Chromatography</topic><topic>Chromatography, High Pressure Liquid - instrumentation</topic><topic>Chromatography, High Pressure Liquid - methods</topic><topic>Chromatography, Reverse-Phase - instrumentation</topic><topic>Chromatography, Reverse-Phase - methods</topic><topic>Conferences</topic><topic>Enantiomers</topic><topic>Enantioselective chromatography</topic><topic>General pharmacology</topic><topic>Guidelines</topic><topic>Liquid chromatography</topic><topic>Medical sciences</topic><topic>Pharmacology. Drug treatments</topic><topic>Phenylpropionates - chemistry</topic><topic>Pyridazines - chemistry</topic><topic>Separation</topic><topic>Sodium</topic><topic>Stereoisomerism</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Douša, Michal</creatorcontrib><creatorcontrib>Gibala, Petr</creatorcontrib><collection>Istex</collection><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>Solid State and Superconductivity Abstracts</collection><collection>Technology Research Database</collection><collection>Advanced Technologies Database with Aerospace</collection><jtitle>Journal of separation science</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Douša, Michal</au><au>Gibala, Petr</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Rapid determination of ambrisentan enantiomers by enantioselective liquid chromatography using cellulose-based chiral stationary phase in reverse phase mode</atitle><jtitle>Journal of separation science</jtitle><addtitle>J. Sep. Science</addtitle><date>2012-04</date><risdate>2012</risdate><volume>35</volume><issue>7</issue><spage>798</spage><epage>803</epage><pages>798-803</pages><issn>1615-9306</issn><eissn>1615-9314</eissn><abstract>A sensitive, specific, and rapid high‐performance liquid chromatography (HPLC) method for the determination of ambrisentan enantiomers has been developed and validated. Six chiral columns were tested in a reversed‐phase system. Excellent enantioseparation with the resolution more than 2.5 was achieved on Chiralcel OZ‐3R (cellulose 3‐chloro‐4‐methylphenylcarbamate) using mixture of 20 mM sodium formate (pH 3.0) with acetonitrile (55:45; v/v). Validation of the HPLC method including linearity, limit of detection, limit of quantification, precision, accuracy, and selectivity was performed according to the International Conference on Harmonisation (ICH) guidelines. The method has an advantage of a very quick chromatographic separation (less than 6 min) and therefore is highly suitable for routine determination of (R)‐ambrisentan in enantiopure active pharmaceutical ingredient (S)‐ambrisentan.</abstract><cop>Weinheim</cop><pub>Blackwell Publishing Ltd</pub><pmid>22532347</pmid><doi>10.1002/jssc.201101062</doi><tpages>6</tpages></addata></record> |
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| ispartof | Journal of separation science, 2012-04, Vol.35 (7), p.798-803 |
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| subjects | Acetonitrile Adsorption Ambrisentan Analysis Biological and medical sciences Cellulose - chemistry Chiral separation Chromatography Chromatography, High Pressure Liquid - instrumentation Chromatography, High Pressure Liquid - methods Chromatography, Reverse-Phase - instrumentation Chromatography, Reverse-Phase - methods Conferences Enantiomers Enantioselective chromatography General pharmacology Guidelines Liquid chromatography Medical sciences Pharmacology. Drug treatments Phenylpropionates - chemistry Pyridazines - chemistry Separation Sodium Stereoisomerism |
| title | Rapid determination of ambrisentan enantiomers by enantioselective liquid chromatography using cellulose-based chiral stationary phase in reverse phase mode |
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