Application of HPLC mixed-mode chromatography in determining radiochemical purity of [14C] labeled metformin hydrochloride
Metformin is currently prescribed worldwide to treat type 2 diabetes, and therefore, radiolabeled [14C] metformin is often prepared for clinical comparisons of new drug candidates. Prior to using the radiolabeled metformin, the purity needs to be determined to ensure the quality of the material. Whi...
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| Veröffentlicht in: | Journal of labelled compounds & radiopharmaceuticals 2015-04, Vol.58 (4), p.177-179 |
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| container_end_page | 179 |
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| container_issue | 4 |
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| container_title | Journal of labelled compounds & radiopharmaceuticals |
| container_volume | 58 |
| creator | Truong, Van Helmy, Roy Ren, Sumei Schenk, David Waterhouse, David |
| description | Metformin is currently prescribed worldwide to treat type 2 diabetes, and therefore, radiolabeled [14C] metformin is often prepared for clinical comparisons of new drug candidates. Prior to using the radiolabeled metformin, the purity needs to be determined to ensure the quality of the material. While typical reversed‐phase LC methods are often the first choice for purity analysis, they are not suitable for this determination because the compound is poorly retained under these conditions. Mixed‐mode chromatography has been demonstrated to overcome these retention issues, and therefore, this methodology was utilized for the purity determination of radiolabeled metformin.
A mixed‐mode chromatography method was developed for the purity assessment of [14C] metformin. The described robust method easily separated the polar impurity components, allowing for the accurate purity determinations of several batches. |
| doi_str_mv | 10.1002/jlcr.3264 |
| format | Article |
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A mixed‐mode chromatography method was developed for the purity assessment of [14C] metformin. The described robust method easily separated the polar impurity components, allowing for the accurate purity determinations of several batches.</description><identifier>ISSN: 0362-4803</identifier><identifier>EISSN: 1099-1344</identifier><identifier>DOI: 10.1002/jlcr.3264</identifier><identifier>PMID: 25720824</identifier><identifier>CODEN: JLCRD4</identifier><language>eng</language><publisher>England: Blackwell Publishing Ltd</publisher><subject>[14C] labeled metformin hydrochloride ; Carbon Radioisotopes - analysis ; Carbon Radioisotopes - chemistry ; Chromatography, High Pressure Liquid - methods ; Isotope Labeling - methods ; Materials Testing - methods ; Metformin - analysis ; Metformin - chemistry ; mixed-mode chromatography ; Pharmaceutical industry ; radiochemical purity ; Radiopharmaceuticals - analysis ; Radiopharmaceuticals - chemical synthesis ; Reproducibility of Results ; Sensitivity and Specificity</subject><ispartof>Journal of labelled compounds & radiopharmaceuticals, 2015-04, Vol.58 (4), p.177-179</ispartof><rights>Copyright © 2015 John Wiley & Sons, Ltd.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c3514-179bd6935778d5aec5a98d5e0e98b7bffb7f29b5f0def6042e370864df6fed2a3</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%2Fjlcr.3264$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fjlcr.3264$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,777,781,1412,27905,27906,45555,45556</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25720824$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Truong, Van</creatorcontrib><creatorcontrib>Helmy, Roy</creatorcontrib><creatorcontrib>Ren, Sumei</creatorcontrib><creatorcontrib>Schenk, David</creatorcontrib><creatorcontrib>Waterhouse, David</creatorcontrib><title>Application of HPLC mixed-mode chromatography in determining radiochemical purity of [14C] labeled metformin hydrochloride</title><title>Journal of labelled compounds & radiopharmaceuticals</title><addtitle>J. Label Compd. Radiopharm</addtitle><description>Metformin is currently prescribed worldwide to treat type 2 diabetes, and therefore, radiolabeled [14C] metformin is often prepared for clinical comparisons of new drug candidates. Prior to using the radiolabeled metformin, the purity needs to be determined to ensure the quality of the material. While typical reversed‐phase LC methods are often the first choice for purity analysis, they are not suitable for this determination because the compound is poorly retained under these conditions. Mixed‐mode chromatography has been demonstrated to overcome these retention issues, and therefore, this methodology was utilized for the purity determination of radiolabeled metformin.
A mixed‐mode chromatography method was developed for the purity assessment of [14C] metformin. The described robust method easily separated the polar impurity components, allowing for the accurate purity determinations of several batches.</description><subject>[14C] labeled metformin hydrochloride</subject><subject>Carbon Radioisotopes - analysis</subject><subject>Carbon Radioisotopes - chemistry</subject><subject>Chromatography, High Pressure Liquid - methods</subject><subject>Isotope Labeling - methods</subject><subject>Materials Testing - methods</subject><subject>Metformin - analysis</subject><subject>Metformin - chemistry</subject><subject>mixed-mode chromatography</subject><subject>Pharmaceutical industry</subject><subject>radiochemical purity</subject><subject>Radiopharmaceuticals - analysis</subject><subject>Radiopharmaceuticals - chemical synthesis</subject><subject>Reproducibility of Results</subject><subject>Sensitivity and Specificity</subject><issn>0362-4803</issn><issn>1099-1344</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kcFu1DAURS0EotPCgh9AltjQRVo7duJkWUXQgkalINAgELKc-LnjwYmDk4iGr8dhhi6QWPlJPvfoPV2EnlFyRglJz3euCWcszfkDtKKkLBPKOH-IVoTlacILwo7Q8TDsCIl_nD9GR2kmUlKkfIV-XfS9s40are-wN_jqZl3h1t6BTlqvATfb4Fs1-tug-u2MbYc1jBBa29nuFgelrW-20EaDw_0U7Dgvlq-UV9-wUzU40LiF0fglgrezDpF3PlgNT9Ajo9wATw_vCfr0-tXH6ipZv7t8U12sk4ZllCdUlLXOS5YJUehMQZOpMg5AoCxqURtTC5OWdWaIBpMTngITpMi5NrkBnSp2gl7uvX3wPyYYRtnaoQHnVAd-GiTNBRMlKUgW0Rf_oDs_hS5u94eKckJ5pE73VBP8MAQwsg-2VWGWlMilELkUIpdCIvv8YJzqFvQ9-beBCJzvgZ_Wwfx_k3y7rj4clMk-YYcR7u4TKnyXyyWZ3FxfypvqeiM-b97LL-w30W-mOw</recordid><startdate>201504</startdate><enddate>201504</enddate><creator>Truong, Van</creator><creator>Helmy, Roy</creator><creator>Ren, Sumei</creator><creator>Schenk, David</creator><creator>Waterhouse, David</creator><general>Blackwell Publishing Ltd</general><general>Wiley Subscription Services, Inc</general><scope>BSCLL</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>201504</creationdate><title>Application of HPLC mixed-mode chromatography in determining radiochemical purity of [14C] labeled metformin hydrochloride</title><author>Truong, Van ; Helmy, Roy ; Ren, Sumei ; Schenk, David ; Waterhouse, David</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3514-179bd6935778d5aec5a98d5e0e98b7bffb7f29b5f0def6042e370864df6fed2a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>[14C] labeled metformin hydrochloride</topic><topic>Carbon Radioisotopes - analysis</topic><topic>Carbon Radioisotopes - chemistry</topic><topic>Chromatography, High Pressure Liquid - methods</topic><topic>Isotope Labeling - methods</topic><topic>Materials Testing - methods</topic><topic>Metformin - analysis</topic><topic>Metformin - chemistry</topic><topic>mixed-mode chromatography</topic><topic>Pharmaceutical industry</topic><topic>radiochemical purity</topic><topic>Radiopharmaceuticals - analysis</topic><topic>Radiopharmaceuticals - chemical synthesis</topic><topic>Reproducibility of Results</topic><topic>Sensitivity and Specificity</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Truong, Van</creatorcontrib><creatorcontrib>Helmy, Roy</creatorcontrib><creatorcontrib>Ren, Sumei</creatorcontrib><creatorcontrib>Schenk, David</creatorcontrib><creatorcontrib>Waterhouse, David</creatorcontrib><collection>Istex</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 labelled compounds & radiopharmaceuticals</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Truong, Van</au><au>Helmy, Roy</au><au>Ren, Sumei</au><au>Schenk, David</au><au>Waterhouse, David</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Application of HPLC mixed-mode chromatography in determining radiochemical purity of [14C] labeled metformin hydrochloride</atitle><jtitle>Journal of labelled compounds & radiopharmaceuticals</jtitle><addtitle>J. Label Compd. Radiopharm</addtitle><date>2015-04</date><risdate>2015</risdate><volume>58</volume><issue>4</issue><spage>177</spage><epage>179</epage><pages>177-179</pages><issn>0362-4803</issn><eissn>1099-1344</eissn><coden>JLCRD4</coden><abstract>Metformin is currently prescribed worldwide to treat type 2 diabetes, and therefore, radiolabeled [14C] metformin is often prepared for clinical comparisons of new drug candidates. Prior to using the radiolabeled metformin, the purity needs to be determined to ensure the quality of the material. While typical reversed‐phase LC methods are often the first choice for purity analysis, they are not suitable for this determination because the compound is poorly retained under these conditions. Mixed‐mode chromatography has been demonstrated to overcome these retention issues, and therefore, this methodology was utilized for the purity determination of radiolabeled metformin.
A mixed‐mode chromatography method was developed for the purity assessment of [14C] metformin. The described robust method easily separated the polar impurity components, allowing for the accurate purity determinations of several batches.</abstract><cop>England</cop><pub>Blackwell Publishing Ltd</pub><pmid>25720824</pmid><doi>10.1002/jlcr.3264</doi><tpages>3</tpages></addata></record> |
| fulltext | fulltext |
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| ispartof | Journal of labelled compounds & radiopharmaceuticals, 2015-04, Vol.58 (4), p.177-179 |
| issn | 0362-4803 1099-1344 |
| language | eng |
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| source | MEDLINE; Wiley Online Library Journals Frontfile Complete |
| subjects | [14C] labeled metformin hydrochloride Carbon Radioisotopes - analysis Carbon Radioisotopes - chemistry Chromatography, High Pressure Liquid - methods Isotope Labeling - methods Materials Testing - methods Metformin - analysis Metformin - chemistry mixed-mode chromatography Pharmaceutical industry radiochemical purity Radiopharmaceuticals - analysis Radiopharmaceuticals - chemical synthesis Reproducibility of Results Sensitivity and Specificity |
| title | Application of HPLC mixed-mode chromatography in determining radiochemical purity of [14C] labeled metformin hydrochloride |
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