Size exclusion HPLC method for the determination of acidic fibroblast growth factor in viscous formulations
A size exclusion HPLC method has been developed to determine the protein concentration of pharmaceutical formulations of recombinant acidic fibroblast growth factor (aFGF). These topical aFGF formulations not only contain low levels of protein mass (50 μg ml−1), but also include buffer ions, polysac...
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| Veröffentlicht in: | Journal of pharmaceutical and biomedical analysis 1997-08, Vol.15 (12), p.1929-1935 |
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| container_end_page | 1935 |
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| container_issue | 12 |
| container_start_page | 1929 |
| container_title | Journal of pharmaceutical and biomedical analysis |
| container_volume | 15 |
| creator | Bruner, Mark W. Goldstein, Joel Russell Middaugh, C. Brooks, Marvin A. Volkin, David B. |
| description | A size exclusion HPLC method has been developed to determine the protein concentration of pharmaceutical formulations of recombinant acidic fibroblast growth factor (aFGF). These topical aFGF formulations not only contain low levels of protein mass (50 μg ml−1), but also include buffer ions, polysaccharide polyanions to conformationally stabilize aFGF and 1% hydroxyethylcellulose to increase the solution's viscosity. A cesium chloride mobile phase is utilized during SEC-HPLC to dissociate aFGF from the pharmaceutical excipients and to minimize nonspecific interaction of the protein with the column matrix. The protein content of a viscous aFGF formulation is determined by comparison of aFGF peak areas to standards of known concentration. Fluorescence spectroscopy was utilized to directly demonstrate that the protein remains in its native conformation during sample preparation and analysis. |
| doi_str_mv | 10.1016/S0731-7085(96)02043-2 |
| format | Article |
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These topical aFGF formulations not only contain low levels of protein mass (50 μg ml−1), but also include buffer ions, polysaccharide polyanions to conformationally stabilize aFGF and 1% hydroxyethylcellulose to increase the solution's viscosity. A cesium chloride mobile phase is utilized during SEC-HPLC to dissociate aFGF from the pharmaceutical excipients and to minimize nonspecific interaction of the protein with the column matrix. The protein content of a viscous aFGF formulation is determined by comparison of aFGF peak areas to standards of known concentration. Fluorescence spectroscopy was utilized to directly demonstrate that the protein remains in its native conformation during sample preparation and analysis.</description><identifier>ISSN: 0731-7085</identifier><identifier>EISSN: 1873-264X</identifier><identifier>DOI: 10.1016/S0731-7085(96)02043-2</identifier><identifier>PMID: 9278899</identifier><identifier>CODEN: JPBADA</identifier><language>eng</language><publisher>Amsterdam: Elsevier B.V</publisher><subject>Acidic fibroblast growth factor ; Analysis ; Biological and medical sciences ; Chemistry, Pharmaceutical ; Chromatography, High Pressure Liquid - methods ; Drug Stability ; Fibroblast Growth Factor 1 - analysis ; Fluorescence spectroscopy ; General pharmacology ; Hydroxyethylcellulose ; Injections ; Linear Models ; Medical sciences ; Pharmacology. Drug treatments ; Protein Conformation ; Recombinant Proteins - analysis ; Reproducibility of Results ; SEC-HPLC ; Viscosity</subject><ispartof>Journal of pharmaceutical and biomedical analysis, 1997-08, Vol.15 (12), p.1929-1935</ispartof><rights>1997</rights><rights>1997 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c389t-a8b40606e4652b4ea6c3af0c752801e7be19c48d9f7068a1d893edc3fdfefbde3</citedby><cites>FETCH-LOGICAL-c389t-a8b40606e4652b4ea6c3af0c752801e7be19c48d9f7068a1d893edc3fdfefbde3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/S0731-7085(96)02043-2$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>315,782,786,3554,27933,27934,46004</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=2789981$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/9278899$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Bruner, Mark W.</creatorcontrib><creatorcontrib>Goldstein, Joel</creatorcontrib><creatorcontrib>Russell Middaugh, C.</creatorcontrib><creatorcontrib>Brooks, Marvin A.</creatorcontrib><creatorcontrib>Volkin, David B.</creatorcontrib><title>Size exclusion HPLC method for the determination of acidic fibroblast growth factor in viscous formulations</title><title>Journal of pharmaceutical and biomedical analysis</title><addtitle>J Pharm Biomed Anal</addtitle><description>A size exclusion HPLC method has been developed to determine the protein concentration of pharmaceutical formulations of recombinant acidic fibroblast growth factor (aFGF). These topical aFGF formulations not only contain low levels of protein mass (50 μg ml−1), but also include buffer ions, polysaccharide polyanions to conformationally stabilize aFGF and 1% hydroxyethylcellulose to increase the solution's viscosity. A cesium chloride mobile phase is utilized during SEC-HPLC to dissociate aFGF from the pharmaceutical excipients and to minimize nonspecific interaction of the protein with the column matrix. The protein content of a viscous aFGF formulation is determined by comparison of aFGF peak areas to standards of known concentration. Fluorescence spectroscopy was utilized to directly demonstrate that the protein remains in its native conformation during sample preparation and analysis.</description><subject>Acidic fibroblast growth factor</subject><subject>Analysis</subject><subject>Biological and medical sciences</subject><subject>Chemistry, Pharmaceutical</subject><subject>Chromatography, High Pressure Liquid - methods</subject><subject>Drug Stability</subject><subject>Fibroblast Growth Factor 1 - analysis</subject><subject>Fluorescence spectroscopy</subject><subject>General pharmacology</subject><subject>Hydroxyethylcellulose</subject><subject>Injections</subject><subject>Linear Models</subject><subject>Medical sciences</subject><subject>Pharmacology. Drug treatments</subject><subject>Protein Conformation</subject><subject>Recombinant Proteins - analysis</subject><subject>Reproducibility of Results</subject><subject>SEC-HPLC</subject><subject>Viscosity</subject><issn>0731-7085</issn><issn>1873-264X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>1997</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkE1rFTEUhoNY6rX6EwpZiNTFaDKZySQrKRdthQstVMFdyCQn3rQzk5pk-uGvb-4Hd-sqB87znrw8CJ1S8pkSyr_ckI7RqiOiPZP8E6lJw6r6FVpQ0ZWBN79fo8UBeYPepnRLCGmpbI7Rsaw7IaRcoLsb_w8wPJlhTj5M-PJ6tcQj5HWw2IWI8xqwhQxx9JPOGyI4rI233mDn-xj6QaeM_8TwmNfYaZNLyE_4wScT5rS5Mc7DNpneoSOnhwTv9-8J-vX928_lZbW6uvixPF9VhgmZKy36hnDCoeFt3TeguWHaEdO1tSAUuh6oNI2w0nWEC02tkAysYc46cL0FdoI-7u7ex_B3hpTVWNrAMOgJSifVybppWc0K2O5AE0NKEZy6j37U8VlRojaS1Vay2hhUkqutZFWX3On-g7kfwR5Se6tl_2G_18nowUU9GZ8OWKGkFLRgX3cYFBkPHqJKxsNkwPoIJisb_H-KvAAjHZtL</recordid><startdate>19970801</startdate><enddate>19970801</enddate><creator>Bruner, Mark W.</creator><creator>Goldstein, Joel</creator><creator>Russell Middaugh, C.</creator><creator>Brooks, Marvin A.</creator><creator>Volkin, David B.</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>19970801</creationdate><title>Size exclusion HPLC method for the determination of acidic fibroblast growth factor in viscous formulations</title><author>Bruner, Mark W. ; Goldstein, Joel ; Russell Middaugh, C. ; Brooks, Marvin A. ; Volkin, David B.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c389t-a8b40606e4652b4ea6c3af0c752801e7be19c48d9f7068a1d893edc3fdfefbde3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>1997</creationdate><topic>Acidic fibroblast growth factor</topic><topic>Analysis</topic><topic>Biological and medical sciences</topic><topic>Chemistry, Pharmaceutical</topic><topic>Chromatography, High Pressure Liquid - methods</topic><topic>Drug Stability</topic><topic>Fibroblast Growth Factor 1 - analysis</topic><topic>Fluorescence spectroscopy</topic><topic>General pharmacology</topic><topic>Hydroxyethylcellulose</topic><topic>Injections</topic><topic>Linear Models</topic><topic>Medical sciences</topic><topic>Pharmacology. Drug treatments</topic><topic>Protein Conformation</topic><topic>Recombinant Proteins - analysis</topic><topic>Reproducibility of Results</topic><topic>SEC-HPLC</topic><topic>Viscosity</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Bruner, Mark W.</creatorcontrib><creatorcontrib>Goldstein, Joel</creatorcontrib><creatorcontrib>Russell Middaugh, C.</creatorcontrib><creatorcontrib>Brooks, Marvin A.</creatorcontrib><creatorcontrib>Volkin, David B.</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 pharmaceutical and biomedical analysis</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Bruner, Mark W.</au><au>Goldstein, Joel</au><au>Russell Middaugh, C.</au><au>Brooks, Marvin A.</au><au>Volkin, David B.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Size exclusion HPLC method for the determination of acidic fibroblast growth factor in viscous formulations</atitle><jtitle>Journal of pharmaceutical and biomedical analysis</jtitle><addtitle>J Pharm Biomed Anal</addtitle><date>1997-08-01</date><risdate>1997</risdate><volume>15</volume><issue>12</issue><spage>1929</spage><epage>1935</epage><pages>1929-1935</pages><issn>0731-7085</issn><eissn>1873-264X</eissn><coden>JPBADA</coden><abstract>A size exclusion HPLC method has been developed to determine the protein concentration of pharmaceutical formulations of recombinant acidic fibroblast growth factor (aFGF). These topical aFGF formulations not only contain low levels of protein mass (50 μg ml−1), but also include buffer ions, polysaccharide polyanions to conformationally stabilize aFGF and 1% hydroxyethylcellulose to increase the solution's viscosity. A cesium chloride mobile phase is utilized during SEC-HPLC to dissociate aFGF from the pharmaceutical excipients and to minimize nonspecific interaction of the protein with the column matrix. The protein content of a viscous aFGF formulation is determined by comparison of aFGF peak areas to standards of known concentration. Fluorescence spectroscopy was utilized to directly demonstrate that the protein remains in its native conformation during sample preparation and analysis.</abstract><cop>Amsterdam</cop><pub>Elsevier B.V</pub><pmid>9278899</pmid><doi>10.1016/S0731-7085(96)02043-2</doi><tpages>7</tpages></addata></record> |
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| ispartof | Journal of pharmaceutical and biomedical analysis, 1997-08, Vol.15 (12), p.1929-1935 |
| issn | 0731-7085 1873-264X |
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| source | MEDLINE; Access via ScienceDirect (Elsevier) |
| subjects | Acidic fibroblast growth factor Analysis Biological and medical sciences Chemistry, Pharmaceutical Chromatography, High Pressure Liquid - methods Drug Stability Fibroblast Growth Factor 1 - analysis Fluorescence spectroscopy General pharmacology Hydroxyethylcellulose Injections Linear Models Medical sciences Pharmacology. Drug treatments Protein Conformation Recombinant Proteins - analysis Reproducibility of Results SEC-HPLC Viscosity |
| title | Size exclusion HPLC method for the determination of acidic fibroblast growth factor in viscous formulations |
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