An Efficient HPLC–MS Method for Impurity Profile of Ertapenem
A mass spectrometer compatible, reverse-phase high-performance liquid chromatography method capable to resolve twenty-six impurities and degradation products (DPs) in Ertapenem (ERT) has been developed. Eight dimer impurities ( m / z 951) and two dehydrated dimers ( m / z 933) were baseline resolved...
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| Veröffentlicht in: | Chromatographia 2020-09, Vol.83 (9), p.1095-1105 |
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| creator | Jadhav, Rajiv A. Ahirrao, Vinod K. Pathan, Amin R. Patil, Kiran R. Rane, Vipul P. Yeole, Ravindra D. |
| description | A mass spectrometer compatible, reverse-phase high-performance liquid chromatography method capable to resolve twenty-six impurities and degradation products (DPs) in Ertapenem (ERT) has been developed. Eight dimer impurities (
m
/
z
951) and two dehydrated dimers (
m
/
z
933) were baseline resolved. Out of eight dimers, four dimers are reported the first time. The impurities and DPs were identified using LC–MS/MS. The chromatographic separation was achieved on X-Terra RP 18 (150 × 4.6 mm, 3.5 µm) column using gradient elution. The separation was dependent on the pH of the mobile phase, optimum separation was achieved using the mobile phase of pH 8. Mobile phase-A comprised of a mixture of ammonium formate buffer (pH 8.0), water and acetonitrile in a ratio of 40:60:01; v/v/v. Mobile phase-B comprised of a mixture of ammonium formate buffer (pH 8.0), acetonitrile and methanol in a ratio of 40:50:10; v/v/v. The flow rate was 1.0 mL min
−1
and column was maintained at 40 °C. Considering the fragility of ERT and demand of faster analysis method, the method was further transformed on rapid resolution column with a run time of 10 min. The later method also produced the same kind of selectivity with enhanced sensitivity. |
| doi_str_mv | 10.1007/s10337-020-03928-6 |
| format | Article |
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m
/
z
951) and two dehydrated dimers (
m
/
z
933) were baseline resolved. Out of eight dimers, four dimers are reported the first time. The impurities and DPs were identified using LC–MS/MS. The chromatographic separation was achieved on X-Terra RP 18 (150 × 4.6 mm, 3.5 µm) column using gradient elution. The separation was dependent on the pH of the mobile phase, optimum separation was achieved using the mobile phase of pH 8. Mobile phase-A comprised of a mixture of ammonium formate buffer (pH 8.0), water and acetonitrile in a ratio of 40:60:01; v/v/v. Mobile phase-B comprised of a mixture of ammonium formate buffer (pH 8.0), acetonitrile and methanol in a ratio of 40:50:10; v/v/v. The flow rate was 1.0 mL min
−1
and column was maintained at 40 °C. Considering the fragility of ERT and demand of faster analysis method, the method was further transformed on rapid resolution column with a run time of 10 min. The later method also produced the same kind of selectivity with enhanced sensitivity.</description><identifier>ISSN: 0009-5893</identifier><identifier>EISSN: 1612-1112</identifier><identifier>DOI: 10.1007/s10337-020-03928-6</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject>Acetonitrile ; Analytical Chemistry ; Buffers ; Chemistry ; Chemistry and Materials Science ; Chromatography ; Dehydration ; Demand analysis ; Dimers ; Elution ; Flow velocity ; Fragility ; High performance liquid chromatography ; Impurities ; Ions ; Laboratory Medicine ; Original ; Pharmacy ; Proteomics ; Selectivity ; Sensitivity enhancement ; Separation</subject><ispartof>Chromatographia, 2020-09, Vol.83 (9), p.1095-1105</ispartof><rights>Springer-Verlag GmbH Germany, part of Springer Nature 2020</rights><rights>Springer-Verlag GmbH Germany, part of Springer Nature 2020.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c319t-2960a13affc2bb256843ef498d3745e553d07d2905f361a41f812c85b6701e213</citedby><cites>FETCH-LOGICAL-c319t-2960a13affc2bb256843ef498d3745e553d07d2905f361a41f812c85b6701e213</cites><orcidid>0000-0002-2163-7428 ; 0000-0002-0597-1303 ; 0000-0002-2507-2719</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s10337-020-03928-6$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s10337-020-03928-6$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids></links><search><creatorcontrib>Jadhav, Rajiv A.</creatorcontrib><creatorcontrib>Ahirrao, Vinod K.</creatorcontrib><creatorcontrib>Pathan, Amin R.</creatorcontrib><creatorcontrib>Patil, Kiran R.</creatorcontrib><creatorcontrib>Rane, Vipul P.</creatorcontrib><creatorcontrib>Yeole, Ravindra D.</creatorcontrib><title>An Efficient HPLC–MS Method for Impurity Profile of Ertapenem</title><title>Chromatographia</title><addtitle>Chromatographia</addtitle><description>A mass spectrometer compatible, reverse-phase high-performance liquid chromatography method capable to resolve twenty-six impurities and degradation products (DPs) in Ertapenem (ERT) has been developed. Eight dimer impurities (
m
/
z
951) and two dehydrated dimers (
m
/
z
933) were baseline resolved. Out of eight dimers, four dimers are reported the first time. The impurities and DPs were identified using LC–MS/MS. The chromatographic separation was achieved on X-Terra RP 18 (150 × 4.6 mm, 3.5 µm) column using gradient elution. The separation was dependent on the pH of the mobile phase, optimum separation was achieved using the mobile phase of pH 8. Mobile phase-A comprised of a mixture of ammonium formate buffer (pH 8.0), water and acetonitrile in a ratio of 40:60:01; v/v/v. Mobile phase-B comprised of a mixture of ammonium formate buffer (pH 8.0), acetonitrile and methanol in a ratio of 40:50:10; v/v/v. The flow rate was 1.0 mL min
−1
and column was maintained at 40 °C. Considering the fragility of ERT and demand of faster analysis method, the method was further transformed on rapid resolution column with a run time of 10 min. The later method also produced the same kind of selectivity with enhanced sensitivity.</description><subject>Acetonitrile</subject><subject>Analytical Chemistry</subject><subject>Buffers</subject><subject>Chemistry</subject><subject>Chemistry and Materials Science</subject><subject>Chromatography</subject><subject>Dehydration</subject><subject>Demand analysis</subject><subject>Dimers</subject><subject>Elution</subject><subject>Flow velocity</subject><subject>Fragility</subject><subject>High performance liquid chromatography</subject><subject>Impurities</subject><subject>Ions</subject><subject>Laboratory Medicine</subject><subject>Original</subject><subject>Pharmacy</subject><subject>Proteomics</subject><subject>Selectivity</subject><subject>Sensitivity enhancement</subject><subject>Separation</subject><issn>0009-5893</issn><issn>1612-1112</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><recordid>eNp9kN9KwzAUxoMoOKcv4FXA6-g5SZO2VzLGdIMOB-p16NpEO7amJt3F7nwH39AnMVrBO68OH3x_OD9CLhGuESC9CQhCpAw4MBA5z5g6IiNUyBki8mMyAoCcySwXp-QshE2UPFdqRG4nLZ1Z21SNaXs6XxXTz_eP5SNdmv7V1dQ6Txe7bu-b_kBX3tlma6izdOb7sjOt2Z2TE1tug7n4vWPyfDd7ms5Z8XC_mE4KVgnMexbHoERRWlvx9ZpLlSXC2CTPapEm0kgpakhrnoO0QmGZoM2QV5lcqxTQcBRjcjX0dt697U3o9cbtfRsnNU-Eio8liYwuPrgq70LwxurON7vSHzSC_galB1A6gtI_oLSKITGEQjS3L8b_Vf-T-gIbjWkr</recordid><startdate>20200901</startdate><enddate>20200901</enddate><creator>Jadhav, Rajiv A.</creator><creator>Ahirrao, Vinod K.</creator><creator>Pathan, Amin R.</creator><creator>Patil, Kiran R.</creator><creator>Rane, Vipul P.</creator><creator>Yeole, Ravindra D.</creator><general>Springer Berlin Heidelberg</general><general>Springer Nature B.V</general><scope>AAYXX</scope><scope>CITATION</scope><orcidid>https://orcid.org/0000-0002-2163-7428</orcidid><orcidid>https://orcid.org/0000-0002-0597-1303</orcidid><orcidid>https://orcid.org/0000-0002-2507-2719</orcidid></search><sort><creationdate>20200901</creationdate><title>An Efficient HPLC–MS Method for Impurity Profile of Ertapenem</title><author>Jadhav, Rajiv A. ; Ahirrao, Vinod K. ; Pathan, Amin R. ; Patil, Kiran R. ; Rane, Vipul P. ; Yeole, Ravindra D.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c319t-2960a13affc2bb256843ef498d3745e553d07d2905f361a41f812c85b6701e213</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Acetonitrile</topic><topic>Analytical Chemistry</topic><topic>Buffers</topic><topic>Chemistry</topic><topic>Chemistry and Materials Science</topic><topic>Chromatography</topic><topic>Dehydration</topic><topic>Demand analysis</topic><topic>Dimers</topic><topic>Elution</topic><topic>Flow velocity</topic><topic>Fragility</topic><topic>High performance liquid chromatography</topic><topic>Impurities</topic><topic>Ions</topic><topic>Laboratory Medicine</topic><topic>Original</topic><topic>Pharmacy</topic><topic>Proteomics</topic><topic>Selectivity</topic><topic>Sensitivity enhancement</topic><topic>Separation</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Jadhav, Rajiv A.</creatorcontrib><creatorcontrib>Ahirrao, Vinod K.</creatorcontrib><creatorcontrib>Pathan, Amin R.</creatorcontrib><creatorcontrib>Patil, Kiran R.</creatorcontrib><creatorcontrib>Rane, Vipul P.</creatorcontrib><creatorcontrib>Yeole, Ravindra D.</creatorcontrib><collection>CrossRef</collection><jtitle>Chromatographia</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Jadhav, Rajiv A.</au><au>Ahirrao, Vinod K.</au><au>Pathan, Amin R.</au><au>Patil, Kiran R.</au><au>Rane, Vipul P.</au><au>Yeole, Ravindra D.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>An Efficient HPLC–MS Method for Impurity Profile of Ertapenem</atitle><jtitle>Chromatographia</jtitle><stitle>Chromatographia</stitle><date>2020-09-01</date><risdate>2020</risdate><volume>83</volume><issue>9</issue><spage>1095</spage><epage>1105</epage><pages>1095-1105</pages><issn>0009-5893</issn><eissn>1612-1112</eissn><abstract>A mass spectrometer compatible, reverse-phase high-performance liquid chromatography method capable to resolve twenty-six impurities and degradation products (DPs) in Ertapenem (ERT) has been developed. Eight dimer impurities (
m
/
z
951) and two dehydrated dimers (
m
/
z
933) were baseline resolved. Out of eight dimers, four dimers are reported the first time. The impurities and DPs were identified using LC–MS/MS. The chromatographic separation was achieved on X-Terra RP 18 (150 × 4.6 mm, 3.5 µm) column using gradient elution. The separation was dependent on the pH of the mobile phase, optimum separation was achieved using the mobile phase of pH 8. Mobile phase-A comprised of a mixture of ammonium formate buffer (pH 8.0), water and acetonitrile in a ratio of 40:60:01; v/v/v. Mobile phase-B comprised of a mixture of ammonium formate buffer (pH 8.0), acetonitrile and methanol in a ratio of 40:50:10; v/v/v. The flow rate was 1.0 mL min
−1
and column was maintained at 40 °C. Considering the fragility of ERT and demand of faster analysis method, the method was further transformed on rapid resolution column with a run time of 10 min. The later method also produced the same kind of selectivity with enhanced sensitivity.</abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><doi>10.1007/s10337-020-03928-6</doi><tpages>11</tpages><orcidid>https://orcid.org/0000-0002-2163-7428</orcidid><orcidid>https://orcid.org/0000-0002-0597-1303</orcidid><orcidid>https://orcid.org/0000-0002-2507-2719</orcidid></addata></record> |
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| source | Springer Nature - Complete Springer Journals |
| subjects | Acetonitrile Analytical Chemistry Buffers Chemistry Chemistry and Materials Science Chromatography Dehydration Demand analysis Dimers Elution Flow velocity Fragility High performance liquid chromatography Impurities Ions Laboratory Medicine Original Pharmacy Proteomics Selectivity Sensitivity enhancement Separation |
| title | An Efficient HPLC–MS Method for Impurity Profile of Ertapenem |
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