A simple, sensitive, high-resolution, customized, reverse phase ultra-high performance liquid chromatographic method for related substances of a therapeutic peptide (bivalirudin trifluoroacetate) using the quality by design approach
Among all chemical sameness characterization tests of Therapeutic Peptides (TPs), one of the most significant and challenging aspects is to demonstrate comparable impurity profiles (both qualitative & quantitative) between a generic product and reference listed drug (RLD). Though multiple state...
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| Veröffentlicht in: | Analytical methods 2020-01, Vol.12 (3), p.34-316 |
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| creator | Kumar, K. Y. Kiran Dama, Venugopala Rao Suchitra, Ch Maringanti, Thirumala Chary |
| description | Among all chemical sameness characterization tests of Therapeutic Peptides (TPs), one of the most significant and challenging aspects is to demonstrate comparable impurity profiles (both qualitative & quantitative) between a generic product and reference listed drug (RLD). Though multiple state of the art orthogonal analytical methods are being used for the identification and quantification of related impurities in TPs, it is important that the developed methods are simple, selective, and sensitive, and can be easily implementable in quality control laboratories. The current published chromatographic (HPLC or UHPLC) methods for the quantification of related substances in TPs rarely use non-mass spectrometry compatible ion pairing reagents (NMS-IPRs) in the mobile phase composition over mass spectrometry compatible ion pairing reagents (MS-IPRs), due to their compatibility issues with high-resolution mass-based detection methods. We hypothesize that achieving mixed mode stationary phase characteristics using hydrophobic NMS-IPRs such as sodium 1-butanesulfonate, at concentrations 2.0 between Penta-Gly & BIV, and a peak to valley ratio (Hp/Hv) > 4.0 between BIV & D-Asn and D-Asn & Tri-Gly impurities. The developed method is sensitive (LOQ ∼ 0.05% with respect to analyte concentration), precise, accurate, and linear in the range of 1 μg mL
−1
to 2500 μg mL
−1
. This method is rugged, robust, and easily implementable in quality control laboratories for monitoring the related impurities of bivalirudin.
Among all chemical sameness characterization tests of Therapeutic Peptides (TPs), one of the most significant and challenging aspects is to demonstrate comparable impurity profiles (both qualitative & quantitative) between a generic product and reference listed drug (RLD). |
| doi_str_mv | 10.1039/c9ay01998g |
| format | Article |
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−1
to 2500 μg mL
−1
. This method is rugged, robust, and easily implementable in quality control laboratories for monitoring the related impurities of bivalirudin.
Among all chemical sameness characterization tests of Therapeutic Peptides (TPs), one of the most significant and challenging aspects is to demonstrate comparable impurity profiles (both qualitative & quantitative) between a generic product and reference listed drug (RLD).]]></description><identifier>ISSN: 1759-9660</identifier><identifier>EISSN: 1759-9679</identifier><identifier>DOI: 10.1039/c9ay01998g</identifier><language>eng</language><publisher>Cambridge: Royal Society of Chemistry</publisher><subject>Analytical methods ; Chromatography ; Compatibility ; High performance liquid chromatography ; High resolution ; Hydrophobicity ; Identification methods ; Impurities ; Laboratories ; Liquid chromatography ; Mass spectrometry ; Mass spectroscopy ; Methods ; Organic chemistry ; Peptides ; Phase composition ; Quality control ; Reagents ; Scientific imaging ; Spectroscopy ; Stationary phase ; Trifluoroacetates</subject><ispartof>Analytical methods, 2020-01, Vol.12 (3), p.34-316</ispartof><rights>Copyright Royal Society of Chemistry 2020</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c318t-d522ba537e54d46cdc53ddb4c00ee5ea304704aabaab282e33937ff133031a483</citedby><cites>FETCH-LOGICAL-c318t-d522ba537e54d46cdc53ddb4c00ee5ea304704aabaab282e33937ff133031a483</cites><orcidid>0000-0002-8914-7265 ; 0000-0001-7586-1970</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids></links><search><creatorcontrib>Kumar, K. Y. Kiran</creatorcontrib><creatorcontrib>Dama, Venugopala Rao</creatorcontrib><creatorcontrib>Suchitra, Ch</creatorcontrib><creatorcontrib>Maringanti, Thirumala Chary</creatorcontrib><title>A simple, sensitive, high-resolution, customized, reverse phase ultra-high performance liquid chromatographic method for related substances of a therapeutic peptide (bivalirudin trifluoroacetate) using the quality by design approach</title><title>Analytical methods</title><description><![CDATA[Among all chemical sameness characterization tests of Therapeutic Peptides (TPs), one of the most significant and challenging aspects is to demonstrate comparable impurity profiles (both qualitative & quantitative) between a generic product and reference listed drug (RLD). Though multiple state of the art orthogonal analytical methods are being used for the identification and quantification of related impurities in TPs, it is important that the developed methods are simple, selective, and sensitive, and can be easily implementable in quality control laboratories. The current published chromatographic (HPLC or UHPLC) methods for the quantification of related substances in TPs rarely use non-mass spectrometry compatible ion pairing reagents (NMS-IPRs) in the mobile phase composition over mass spectrometry compatible ion pairing reagents (MS-IPRs), due to their compatibility issues with high-resolution mass-based detection methods. We hypothesize that achieving mixed mode stationary phase characteristics using hydrophobic NMS-IPRs such as sodium 1-butanesulfonate, at concentrations <10 mM in the diethanolammonium phosphate buffer (pH 2.9) on a C-18 stationary phase, would be able to resolve critical impurities such as Penta-Gly, D-Asn, and Tri-Gly using the single UHPLC method, and is also selective to all other related impurities of bivalirudin (BIV) cited in the literature. Furthermore, customization of column dimensions (300 mm × 2.1 mm × 1.8 μm) helped in achieving a resolution (Rs) > 2.0 between Penta-Gly & BIV, and a peak to valley ratio (Hp/Hv) > 4.0 between BIV & D-Asn and D-Asn & Tri-Gly impurities. The developed method is sensitive (LOQ ∼ 0.05% with respect to analyte concentration), precise, accurate, and linear in the range of 1 μg mL
−1
to 2500 μg mL
−1
. This method is rugged, robust, and easily implementable in quality control laboratories for monitoring the related impurities of bivalirudin.
Among all chemical sameness characterization tests of Therapeutic Peptides (TPs), one of the most significant and challenging aspects is to demonstrate comparable impurity profiles (both qualitative & quantitative) between a generic product and reference listed drug (RLD).]]></description><subject>Analytical methods</subject><subject>Chromatography</subject><subject>Compatibility</subject><subject>High performance liquid chromatography</subject><subject>High resolution</subject><subject>Hydrophobicity</subject><subject>Identification methods</subject><subject>Impurities</subject><subject>Laboratories</subject><subject>Liquid chromatography</subject><subject>Mass spectrometry</subject><subject>Mass spectroscopy</subject><subject>Methods</subject><subject>Organic chemistry</subject><subject>Peptides</subject><subject>Phase composition</subject><subject>Quality control</subject><subject>Reagents</subject><subject>Scientific imaging</subject><subject>Spectroscopy</subject><subject>Stationary phase</subject><subject>Trifluoroacetates</subject><issn>1759-9660</issn><issn>1759-9679</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><recordid>eNpFkc2L1EAQxYMouK5evAsFXlQm2p3ufPRxGHQVFrzowVPodFeSXpJ0pj8GZv9i_ww7O8sKRVUdfu-9w8uyt5R8poSJL0rIM6FCNMOz7IrWpchFVYvnT39FXmavvL8jpBKsolfZ3z14M68T7sDj4k0wp_SOZhhzh95OMRi77EBFH-xs7lHvwOEJnUdYR5l2nIKT-SaAFV1v3SwXhTCZYzQa1OjsLIMdnFxHo2DGMFoNCUs2kwyowcfOh03jwfYgIYyYYEzBKjmuwWiED505ycm4qM0CwZl-itZZqTAki48QvVmGTQjHmLBwhu4MGr0ZFpDrupHj6-xFLyePbx7vdfb729dfh-_57c-bH4f9ba4YbUKuy6LoZMlqLLnmldKqZFp3XBGCWKJkhNeES9mlKZoCGROs7nvKGGFU8oZdZ-8vvin2GNGH9s5Gt6TItmCccVE1hCfq04VSznrvsG9XZ2bpzi0l7dZkexD7Pw9N3iT43QV2Xj1x_5tm_wCWGaK9</recordid><startdate>20200123</startdate><enddate>20200123</enddate><creator>Kumar, K. Y. Kiran</creator><creator>Dama, Venugopala Rao</creator><creator>Suchitra, Ch</creator><creator>Maringanti, Thirumala Chary</creator><general>Royal Society of Chemistry</general><scope>AAYXX</scope><scope>CITATION</scope><scope>7QF</scope><scope>7QO</scope><scope>7QQ</scope><scope>7SE</scope><scope>7SR</scope><scope>7U5</scope><scope>8BQ</scope><scope>8FD</scope><scope>FR3</scope><scope>H8G</scope><scope>JG9</scope><scope>L7M</scope><scope>P64</scope><orcidid>https://orcid.org/0000-0002-8914-7265</orcidid><orcidid>https://orcid.org/0000-0001-7586-1970</orcidid></search><sort><creationdate>20200123</creationdate><title>A simple, sensitive, high-resolution, customized, reverse phase ultra-high performance liquid chromatographic method for related substances of a therapeutic peptide (bivalirudin trifluoroacetate) using the quality by design approach</title><author>Kumar, K. Y. Kiran ; Dama, Venugopala Rao ; Suchitra, Ch ; Maringanti, Thirumala Chary</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c318t-d522ba537e54d46cdc53ddb4c00ee5ea304704aabaab282e33937ff133031a483</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Analytical methods</topic><topic>Chromatography</topic><topic>Compatibility</topic><topic>High performance liquid chromatography</topic><topic>High resolution</topic><topic>Hydrophobicity</topic><topic>Identification methods</topic><topic>Impurities</topic><topic>Laboratories</topic><topic>Liquid chromatography</topic><topic>Mass spectrometry</topic><topic>Mass spectroscopy</topic><topic>Methods</topic><topic>Organic chemistry</topic><topic>Peptides</topic><topic>Phase composition</topic><topic>Quality control</topic><topic>Reagents</topic><topic>Scientific imaging</topic><topic>Spectroscopy</topic><topic>Stationary phase</topic><topic>Trifluoroacetates</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kumar, K. Y. Kiran</creatorcontrib><creatorcontrib>Dama, Venugopala Rao</creatorcontrib><creatorcontrib>Suchitra, Ch</creatorcontrib><creatorcontrib>Maringanti, Thirumala Chary</creatorcontrib><collection>CrossRef</collection><collection>Aluminium Industry Abstracts</collection><collection>Biotechnology Research Abstracts</collection><collection>Ceramic Abstracts</collection><collection>Corrosion Abstracts</collection><collection>Engineered Materials Abstracts</collection><collection>Solid State and Superconductivity Abstracts</collection><collection>METADEX</collection><collection>Technology Research Database</collection><collection>Engineering Research Database</collection><collection>Copper Technical Reference Library</collection><collection>Materials Research Database</collection><collection>Advanced Technologies Database with Aerospace</collection><collection>Biotechnology and BioEngineering Abstracts</collection><jtitle>Analytical methods</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kumar, K. Y. Kiran</au><au>Dama, Venugopala Rao</au><au>Suchitra, Ch</au><au>Maringanti, Thirumala Chary</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A simple, sensitive, high-resolution, customized, reverse phase ultra-high performance liquid chromatographic method for related substances of a therapeutic peptide (bivalirudin trifluoroacetate) using the quality by design approach</atitle><jtitle>Analytical methods</jtitle><date>2020-01-23</date><risdate>2020</risdate><volume>12</volume><issue>3</issue><spage>34</spage><epage>316</epage><pages>34-316</pages><issn>1759-9660</issn><eissn>1759-9679</eissn><abstract><![CDATA[Among all chemical sameness characterization tests of Therapeutic Peptides (TPs), one of the most significant and challenging aspects is to demonstrate comparable impurity profiles (both qualitative & quantitative) between a generic product and reference listed drug (RLD). Though multiple state of the art orthogonal analytical methods are being used for the identification and quantification of related impurities in TPs, it is important that the developed methods are simple, selective, and sensitive, and can be easily implementable in quality control laboratories. The current published chromatographic (HPLC or UHPLC) methods for the quantification of related substances in TPs rarely use non-mass spectrometry compatible ion pairing reagents (NMS-IPRs) in the mobile phase composition over mass spectrometry compatible ion pairing reagents (MS-IPRs), due to their compatibility issues with high-resolution mass-based detection methods. We hypothesize that achieving mixed mode stationary phase characteristics using hydrophobic NMS-IPRs such as sodium 1-butanesulfonate, at concentrations <10 mM in the diethanolammonium phosphate buffer (pH 2.9) on a C-18 stationary phase, would be able to resolve critical impurities such as Penta-Gly, D-Asn, and Tri-Gly using the single UHPLC method, and is also selective to all other related impurities of bivalirudin (BIV) cited in the literature. Furthermore, customization of column dimensions (300 mm × 2.1 mm × 1.8 μm) helped in achieving a resolution (Rs) > 2.0 between Penta-Gly & BIV, and a peak to valley ratio (Hp/Hv) > 4.0 between BIV & D-Asn and D-Asn & Tri-Gly impurities. The developed method is sensitive (LOQ ∼ 0.05% with respect to analyte concentration), precise, accurate, and linear in the range of 1 μg mL
−1
to 2500 μg mL
−1
. This method is rugged, robust, and easily implementable in quality control laboratories for monitoring the related impurities of bivalirudin.
Among all chemical sameness characterization tests of Therapeutic Peptides (TPs), one of the most significant and challenging aspects is to demonstrate comparable impurity profiles (both qualitative & quantitative) between a generic product and reference listed drug (RLD).]]></abstract><cop>Cambridge</cop><pub>Royal Society of Chemistry</pub><doi>10.1039/c9ay01998g</doi><tpages>13</tpages><orcidid>https://orcid.org/0000-0002-8914-7265</orcidid><orcidid>https://orcid.org/0000-0001-7586-1970</orcidid></addata></record> |
| fulltext | fulltext |
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| ispartof | Analytical methods, 2020-01, Vol.12 (3), p.34-316 |
| issn | 1759-9660 1759-9679 |
| language | eng |
| recordid | cdi_crossref_primary_10_1039_C9AY01998G |
| source | Royal Society Of Chemistry Journals 2008- |
| subjects | Analytical methods Chromatography Compatibility High performance liquid chromatography High resolution Hydrophobicity Identification methods Impurities Laboratories Liquid chromatography Mass spectrometry Mass spectroscopy Methods Organic chemistry Peptides Phase composition Quality control Reagents Scientific imaging Spectroscopy Stationary phase Trifluoroacetates |
| title | A simple, sensitive, high-resolution, customized, reverse phase ultra-high performance liquid chromatographic method for related substances of a therapeutic peptide (bivalirudin trifluoroacetate) using the quality by design approach |
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