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Comparison of LC detection methods in the investigation of non-UV detectable organic impurities in a drug substance
HPLC Analysis with different detection methods was shown to be essential in the separation and identification of unknown organic impurities in a drug substance. The impurities were found to exhibit very weak or no response to standard ultraviolet (UV) absorption detection. LC-MS, LC-NMR, indirect, r...
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| Published in: | Journal of pharmaceutical and biomedical analysis 1998-07, Vol.17 (3), p.455-471 |
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| Main Authors: | , , , |
| Format: | Article |
| Language: | English |
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| cited_by | cdi_FETCH-LOGICAL-c389t-c0a17d1f905881f92bca41e6b27116985efed745fd427f9cfc0b7e0640b1f2123 |
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| cites | cdi_FETCH-LOGICAL-c389t-c0a17d1f905881f92bca41e6b27116985efed745fd427f9cfc0b7e0640b1f2123 |
| container_end_page | 471 |
| container_issue | 3 |
| container_start_page | 455 |
| container_title | Journal of pharmaceutical and biomedical analysis |
| container_volume | 17 |
| creator | McCrossen, S.D. Bryant, D.K. Cook, B.R. Richards, J.J. |
| description | HPLC Analysis with different detection methods was shown to be essential in the separation and identification of unknown organic impurities in a drug substance. The impurities were found to exhibit very weak or no response to standard ultraviolet (UV) absorption detection. LC-MS, LC-NMR, indirect, refractive index and evaporative light-scattering detection were used to quantify and identify the impurities in this specific case. The drug substance studied was found to be an ideal analyte for demonstrating the advantages and limitations of several chromatographic detection systems for impurity profile analysis. |
| doi_str_mv | 10.1016/S0731-7085(97)00235-5 |
| format | article |
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The impurities were found to exhibit very weak or no response to standard ultraviolet (UV) absorption detection. LC-MS, LC-NMR, indirect, refractive index and evaporative light-scattering detection were used to quantify and identify the impurities in this specific case. The drug substance studied was found to be an ideal analyte for demonstrating the advantages and limitations of several chromatographic detection systems for impurity profile analysis.</description><identifier>ISSN: 0731-7085</identifier><identifier>EISSN: 1873-264X</identifier><identifier>DOI: 10.1016/S0731-7085(97)00235-5</identifier><identifier>PMID: 9656157</identifier><identifier>CODEN: JPBADA</identifier><language>eng</language><publisher>Amsterdam: Elsevier B.V</publisher><subject>Analysis ; Biological and medical sciences ; Chromatography, High Pressure Liquid - methods ; Chromatography, Liquid - methods ; Detection ; Drug Contamination ; Drug substance ; Evaporative light scattering ; General pharmacology ; Impurities ; Indirect detection ; LC-MS ; LC-NMR ; Light ; Magnetic Resonance Spectroscopy - methods ; Medical sciences ; Pharmacology. 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The impurities were found to exhibit very weak or no response to standard ultraviolet (UV) absorption detection. LC-MS, LC-NMR, indirect, refractive index and evaporative light-scattering detection were used to quantify and identify the impurities in this specific case. The drug substance studied was found to be an ideal analyte for demonstrating the advantages and limitations of several chromatographic detection systems for impurity profile analysis.</description><subject>Analysis</subject><subject>Biological and medical sciences</subject><subject>Chromatography, High Pressure Liquid - methods</subject><subject>Chromatography, Liquid - methods</subject><subject>Detection</subject><subject>Drug Contamination</subject><subject>Drug substance</subject><subject>Evaporative light scattering</subject><subject>General pharmacology</subject><subject>Impurities</subject><subject>Indirect detection</subject><subject>LC-MS</subject><subject>LC-NMR</subject><subject>Light</subject><subject>Magnetic Resonance Spectroscopy - methods</subject><subject>Medical sciences</subject><subject>Pharmacology. Drug treatments</subject><subject>Refractive index</subject><subject>Refractometry - methods</subject><subject>Sensitivity and Specificity</subject><subject>Spectrophotometry, Ultraviolet - methods</subject><issn>0731-7085</issn><issn>1873-264X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>1998</creationdate><recordtype>article</recordtype><recordid>eNqFkE1r3DAQhkVoSLZJfkJAh1LSgxNJtizrVMKSj8JCDvkgNyFLo42KbW0lO5B_H2XX7LWnQczzjmYehM4puaSE1lePRJS0EKThF1L8IoSVvOAHaEEbURasrl6_ocUeOUbfU_pLCOFUVkfoSNa8plwsUFqGfqOjT2HAweHVElsYwYw-v3sY34JN2A94fINc3iGNfq23zQwPYSieX-aAbjvAIa714A32_WaKfvSwDWts47TGaWrTqAcDp-jQ6S7B2VxP0PPtzdPyvlg93P1ZXq8KUzZyLAzRVFjqJOFNkwtrja4o1C0TlNay4eDAioo7WzHhpHGGtAJIXZGWOkZZeYJ-7uZuYvg35d1V75OBrtMDhCkpIaVkpKozyHegiSGlCE5tou91_FCUqC_ZaitbfZlUUqitbMVz7nz-YGp7sPvUbDf3f8x9nYzuXMzX-7THWFnKPDZjv3cYZBnvHqJKxkMWZX3MZpUN_j-LfAIiTJyp</recordid><startdate>19980701</startdate><enddate>19980701</enddate><creator>McCrossen, S.D.</creator><creator>Bryant, D.K.</creator><creator>Cook, B.R.</creator><creator>Richards, J.J.</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>19980701</creationdate><title>Comparison of LC detection methods in the investigation of non-UV detectable organic impurities in a drug substance</title><author>McCrossen, S.D. ; Bryant, D.K. ; Cook, B.R. ; Richards, J.J.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c389t-c0a17d1f905881f92bca41e6b27116985efed745fd427f9cfc0b7e0640b1f2123</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>1998</creationdate><topic>Analysis</topic><topic>Biological and medical sciences</topic><topic>Chromatography, High Pressure Liquid - methods</topic><topic>Chromatography, Liquid - methods</topic><topic>Detection</topic><topic>Drug Contamination</topic><topic>Drug substance</topic><topic>Evaporative light scattering</topic><topic>General pharmacology</topic><topic>Impurities</topic><topic>Indirect detection</topic><topic>LC-MS</topic><topic>LC-NMR</topic><topic>Light</topic><topic>Magnetic Resonance Spectroscopy - methods</topic><topic>Medical sciences</topic><topic>Pharmacology. Drug treatments</topic><topic>Refractive index</topic><topic>Refractometry - methods</topic><topic>Sensitivity and Specificity</topic><topic>Spectrophotometry, Ultraviolet - methods</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>McCrossen, S.D.</creatorcontrib><creatorcontrib>Bryant, D.K.</creatorcontrib><creatorcontrib>Cook, B.R.</creatorcontrib><creatorcontrib>Richards, J.J.</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>McCrossen, S.D.</au><au>Bryant, D.K.</au><au>Cook, B.R.</au><au>Richards, J.J.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Comparison of LC detection methods in the investigation of non-UV detectable organic impurities in a drug substance</atitle><jtitle>Journal of pharmaceutical and biomedical analysis</jtitle><addtitle>J Pharm Biomed Anal</addtitle><date>1998-07-01</date><risdate>1998</risdate><volume>17</volume><issue>3</issue><spage>455</spage><epage>471</epage><pages>455-471</pages><issn>0731-7085</issn><eissn>1873-264X</eissn><coden>JPBADA</coden><abstract>HPLC Analysis with different detection methods was shown to be essential in the separation and identification of unknown organic impurities in a drug substance. The impurities were found to exhibit very weak or no response to standard ultraviolet (UV) absorption detection. LC-MS, LC-NMR, indirect, refractive index and evaporative light-scattering detection were used to quantify and identify the impurities in this specific case. The drug substance studied was found to be an ideal analyte for demonstrating the advantages and limitations of several chromatographic detection systems for impurity profile analysis.</abstract><cop>Amsterdam</cop><pub>Elsevier B.V</pub><pmid>9656157</pmid><doi>10.1016/S0731-7085(97)00235-5</doi><tpages>17</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0731-7085 |
| ispartof | Journal of pharmaceutical and biomedical analysis, 1998-07, Vol.17 (3), p.455-471 |
| issn | 0731-7085 1873-264X |
| language | eng |
| recordid | cdi_proquest_miscellaneous_79992046 |
| source | ScienceDirect Journals |
| subjects | Analysis Biological and medical sciences Chromatography, High Pressure Liquid - methods Chromatography, Liquid - methods Detection Drug Contamination Drug substance Evaporative light scattering General pharmacology Impurities Indirect detection LC-MS LC-NMR Light Magnetic Resonance Spectroscopy - methods Medical sciences Pharmacology. Drug treatments Refractive index Refractometry - methods Sensitivity and Specificity Spectrophotometry, Ultraviolet - methods |
| title | Comparison of LC detection methods in the investigation of non-UV detectable organic impurities in a drug substance |
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