Development and validation of a GC-FID method for quantitation of impurities in kemantane drug substance
The objective of the study was to develop and validate a new GC-FID method for determination of impurities in kemantane (5-hydroxyadamantan-2-one) drug substance. The chromatographic mobilities of potential impurities in kemantane such as adamantan-2-one, adamantan-1-ol, adamantan-2-ol, adamantane-1...
Gespeichert in:
| Veröffentlicht in: | Pharmaceutical chemistry journal 2013-09, Vol.47 (6), p.330-336 |
|---|---|
| Hauptverfasser: | , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 336 |
|---|---|
| container_issue | 6 |
| container_start_page | 330 |
| container_title | Pharmaceutical chemistry journal |
| container_volume | 47 |
| creator | Tolkacheva, A. V. Grushevskaya, L. N. Avdyunina, N. I. Pyatin, B. M. Prokofeva, V. I. Gaevaya, L. M. |
| description | The objective of the study was to develop and validate a new GC-FID method for determination of impurities in kemantane (5-hydroxyadamantan-2-one) drug substance. The chromatographic mobilities of potential impurities in kemantane such as adamantan-2-one, adamantan-1-ol, adamantan-2-ol, adamantane-1,4-diol, adamantane-1,4-diol (
syn
-isomer), adamantane-2,6-diol, and adamantane-2,6-dione were studied. The chromatographic separation was performed on a quartz capillary column (VF-624ms, 60 m × 0.32 mm, 1.80 μm film thickness). The chromatographic system suitability parameters and method robustness factor were determined. The method had acceptable specificity, accuracy, linearity, and precision and high sensitivity. The developed method detected an impurity of adamantane-2,6-dione from 1.01 to 2.97% in four batches of kemantane drug substance. |
| doi_str_mv | 10.1007/s11094-013-0955-9 |
| format | Article |
| fullrecord | <record><control><sourceid>gale_cross</sourceid><recordid>TN_cdi_gale_infotracacademiconefile_A352488957</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><galeid>A352488957</galeid><sourcerecordid>A352488957</sourcerecordid><originalsourceid>FETCH-LOGICAL-c327t-22a5cfe5f0d51b4fad5ad8ff6a4934b75ec5b6c4ee4e172d5b84c9bfa1881ef03</originalsourceid><addsrcrecordid>eNp9kM1KAzEQgIMoWKsP4C0vkJrsbrqbY2ltLRS8KHgL2WTSpnaTmuwWfHtTKh5lDsP8fAPzIfTI6IRRWj8lxqioCGUloYJzIq7QiPG6JIKW7BqNKBWMME4_btFdSntKM1UWI7RbwAkO4diB77HyBp_UwRnVu-BxsFjh1Zws1wvcQb8LBtsQ8degfO_6vx3XHYfoegcJO48_octj5QGbOGxxGtqUKw336MaqQ4KH3zxG78vnt_kL2byu1vPZhuiyqHtSFIprC9xSw1lbWWW4Mo21U1WJsmprDpq3U10BVMDqwvC2qbRorWJNw8DScowml7tbdQDpvA19VDqHgc7p4MG63J-VvKiaRmRDY8QugI4hpQhWHqPrVPyWjMqzW3lxK7NbeXYrRWaKC5Pyrt9ClPswRJ__-gf6ASDgfm8</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype></control><display><type>article</type><title>Development and validation of a GC-FID method for quantitation of impurities in kemantane drug substance</title><source>SpringerNature Journals</source><creator>Tolkacheva, A. V. ; Grushevskaya, L. N. ; Avdyunina, N. I. ; Pyatin, B. M. ; Prokofeva, V. I. ; Gaevaya, L. M.</creator><creatorcontrib>Tolkacheva, A. V. ; Grushevskaya, L. N. ; Avdyunina, N. I. ; Pyatin, B. M. ; Prokofeva, V. I. ; Gaevaya, L. M.</creatorcontrib><description>The objective of the study was to develop and validate a new GC-FID method for determination of impurities in kemantane (5-hydroxyadamantan-2-one) drug substance. The chromatographic mobilities of potential impurities in kemantane such as adamantan-2-one, adamantan-1-ol, adamantan-2-ol, adamantane-1,4-diol, adamantane-1,4-diol (
syn
-isomer), adamantane-2,6-diol, and adamantane-2,6-dione were studied. The chromatographic separation was performed on a quartz capillary column (VF-624ms, 60 m × 0.32 mm, 1.80 μm film thickness). The chromatographic system suitability parameters and method robustness factor were determined. The method had acceptable specificity, accuracy, linearity, and precision and high sensitivity. The developed method detected an impurity of adamantane-2,6-dione from 1.01 to 2.97% in four batches of kemantane drug substance.</description><identifier>ISSN: 0091-150X</identifier><identifier>EISSN: 1573-9031</identifier><identifier>DOI: 10.1007/s11094-013-0955-9</identifier><language>eng</language><publisher>Boston: Springer US</publisher><subject>Analysis ; Chromatography ; Medicine ; Methods ; Organic Chemistry ; Pharmacology/Toxicology ; Pharmacy</subject><ispartof>Pharmaceutical chemistry journal, 2013-09, Vol.47 (6), p.330-336</ispartof><rights>Springer Science+Business Media New York 2013</rights><rights>COPYRIGHT 2013 Springer</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c327t-22a5cfe5f0d51b4fad5ad8ff6a4934b75ec5b6c4ee4e172d5b84c9bfa1881ef03</citedby><cites>FETCH-LOGICAL-c327t-22a5cfe5f0d51b4fad5ad8ff6a4934b75ec5b6c4ee4e172d5b84c9bfa1881ef03</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s11094-013-0955-9$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s11094-013-0955-9$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,780,784,27924,27925,41488,42557,51319</link.rule.ids></links><search><creatorcontrib>Tolkacheva, A. V.</creatorcontrib><creatorcontrib>Grushevskaya, L. N.</creatorcontrib><creatorcontrib>Avdyunina, N. I.</creatorcontrib><creatorcontrib>Pyatin, B. M.</creatorcontrib><creatorcontrib>Prokofeva, V. I.</creatorcontrib><creatorcontrib>Gaevaya, L. M.</creatorcontrib><title>Development and validation of a GC-FID method for quantitation of impurities in kemantane drug substance</title><title>Pharmaceutical chemistry journal</title><addtitle>Pharm Chem J</addtitle><description>The objective of the study was to develop and validate a new GC-FID method for determination of impurities in kemantane (5-hydroxyadamantan-2-one) drug substance. The chromatographic mobilities of potential impurities in kemantane such as adamantan-2-one, adamantan-1-ol, adamantan-2-ol, adamantane-1,4-diol, adamantane-1,4-diol (
syn
-isomer), adamantane-2,6-diol, and adamantane-2,6-dione were studied. The chromatographic separation was performed on a quartz capillary column (VF-624ms, 60 m × 0.32 mm, 1.80 μm film thickness). The chromatographic system suitability parameters and method robustness factor were determined. The method had acceptable specificity, accuracy, linearity, and precision and high sensitivity. The developed method detected an impurity of adamantane-2,6-dione from 1.01 to 2.97% in four batches of kemantane drug substance.</description><subject>Analysis</subject><subject>Chromatography</subject><subject>Medicine</subject><subject>Methods</subject><subject>Organic Chemistry</subject><subject>Pharmacology/Toxicology</subject><subject>Pharmacy</subject><issn>0091-150X</issn><issn>1573-9031</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><recordid>eNp9kM1KAzEQgIMoWKsP4C0vkJrsbrqbY2ltLRS8KHgL2WTSpnaTmuwWfHtTKh5lDsP8fAPzIfTI6IRRWj8lxqioCGUloYJzIq7QiPG6JIKW7BqNKBWMME4_btFdSntKM1UWI7RbwAkO4diB77HyBp_UwRnVu-BxsFjh1Zws1wvcQb8LBtsQ8degfO_6vx3XHYfoegcJO48_octj5QGbOGxxGtqUKw336MaqQ4KH3zxG78vnt_kL2byu1vPZhuiyqHtSFIprC9xSw1lbWWW4Mo21U1WJsmprDpq3U10BVMDqwvC2qbRorWJNw8DScowml7tbdQDpvA19VDqHgc7p4MG63J-VvKiaRmRDY8QugI4hpQhWHqPrVPyWjMqzW3lxK7NbeXYrRWaKC5Pyrt9ClPswRJ__-gf6ASDgfm8</recordid><startdate>20130901</startdate><enddate>20130901</enddate><creator>Tolkacheva, A. V.</creator><creator>Grushevskaya, L. N.</creator><creator>Avdyunina, N. I.</creator><creator>Pyatin, B. M.</creator><creator>Prokofeva, V. I.</creator><creator>Gaevaya, L. M.</creator><general>Springer US</general><general>Springer</general><scope>AAYXX</scope><scope>CITATION</scope></search><sort><creationdate>20130901</creationdate><title>Development and validation of a GC-FID method for quantitation of impurities in kemantane drug substance</title><author>Tolkacheva, A. V. ; Grushevskaya, L. N. ; Avdyunina, N. I. ; Pyatin, B. M. ; Prokofeva, V. I. ; Gaevaya, L. M.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c327t-22a5cfe5f0d51b4fad5ad8ff6a4934b75ec5b6c4ee4e172d5b84c9bfa1881ef03</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Analysis</topic><topic>Chromatography</topic><topic>Medicine</topic><topic>Methods</topic><topic>Organic Chemistry</topic><topic>Pharmacology/Toxicology</topic><topic>Pharmacy</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Tolkacheva, A. V.</creatorcontrib><creatorcontrib>Grushevskaya, L. N.</creatorcontrib><creatorcontrib>Avdyunina, N. I.</creatorcontrib><creatorcontrib>Pyatin, B. M.</creatorcontrib><creatorcontrib>Prokofeva, V. I.</creatorcontrib><creatorcontrib>Gaevaya, L. M.</creatorcontrib><collection>CrossRef</collection><jtitle>Pharmaceutical chemistry journal</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Tolkacheva, A. V.</au><au>Grushevskaya, L. N.</au><au>Avdyunina, N. I.</au><au>Pyatin, B. M.</au><au>Prokofeva, V. I.</au><au>Gaevaya, L. M.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Development and validation of a GC-FID method for quantitation of impurities in kemantane drug substance</atitle><jtitle>Pharmaceutical chemistry journal</jtitle><stitle>Pharm Chem J</stitle><date>2013-09-01</date><risdate>2013</risdate><volume>47</volume><issue>6</issue><spage>330</spage><epage>336</epage><pages>330-336</pages><issn>0091-150X</issn><eissn>1573-9031</eissn><abstract>The objective of the study was to develop and validate a new GC-FID method for determination of impurities in kemantane (5-hydroxyadamantan-2-one) drug substance. The chromatographic mobilities of potential impurities in kemantane such as adamantan-2-one, adamantan-1-ol, adamantan-2-ol, adamantane-1,4-diol, adamantane-1,4-diol (
syn
-isomer), adamantane-2,6-diol, and adamantane-2,6-dione were studied. The chromatographic separation was performed on a quartz capillary column (VF-624ms, 60 m × 0.32 mm, 1.80 μm film thickness). The chromatographic system suitability parameters and method robustness factor were determined. The method had acceptable specificity, accuracy, linearity, and precision and high sensitivity. The developed method detected an impurity of adamantane-2,6-dione from 1.01 to 2.97% in four batches of kemantane drug substance.</abstract><cop>Boston</cop><pub>Springer US</pub><doi>10.1007/s11094-013-0955-9</doi><tpages>7</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0091-150X |
| ispartof | Pharmaceutical chemistry journal, 2013-09, Vol.47 (6), p.330-336 |
| issn | 0091-150X 1573-9031 |
| language | eng |
| recordid | cdi_gale_infotracacademiconefile_A352488957 |
| source | SpringerNature Journals |
| subjects | Analysis Chromatography Medicine Methods Organic Chemistry Pharmacology/Toxicology Pharmacy |
| title | Development and validation of a GC-FID method for quantitation of impurities in kemantane drug substance |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-24T21%3A47%3A37IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Development%20and%20validation%20of%20a%20GC-FID%20method%20for%20quantitation%20of%20impurities%20in%20kemantane%20drug%20substance&rft.jtitle=Pharmaceutical%20chemistry%20journal&rft.au=Tolkacheva,%20A.%20V.&rft.date=2013-09-01&rft.volume=47&rft.issue=6&rft.spage=330&rft.epage=336&rft.pages=330-336&rft.issn=0091-150X&rft.eissn=1573-9031&rft_id=info:doi/10.1007/s11094-013-0955-9&rft_dat=%3Cgale_cross%3EA352488957%3C/gale_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_id=info:pmid/&rft_galeid=A352488957&rfr_iscdi=true |