Determination of artemether and lumefantrine in anti-malarial fixed-dose combination tablets by microemulsion electrokinetic chromatography with short-end injection procedure
Artemether-lumefantrine (AL) combination therapy is now the most used anti-malarial treatment in the world. Quality control of AL formulations is still a major challenge in developing countries. Until now, only liquid chromatographic methods have been reported in the literature for their analysis. C...
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| Veröffentlicht in: | Malaria journal 2013-06, Vol.12 (1), p.202-202, Article 202 |
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| creator | Amin, N'Cho Christophe Fabre, Huguette Blanchin, Marie-Dominique Montels, Jérôme Aké, Michèle |
| description | Artemether-lumefantrine (AL) combination therapy is now the most used anti-malarial treatment in the world. Quality control of AL formulations is still a major challenge in developing countries. Until now, only liquid chromatographic methods have been reported in the literature for their analysis. Capillary electrophoretic methods, which present various advantages (low price of capillary, low volumes of electrolyte consumption), may be an alternative to liquid chromatography methods. In this paper, a reliable method was developed and validated for the determination of AL in commercial fixed-dose combination tablets commercialized in Côte d'Ivoire.
Artemether and lumefantrine were determined by microemulsion electrokinetic chromatography using short-end injection procedure. The two analytes were extracted from tablets by acidified methanol. Pyrimethamine was used as internal standard. Separation was carried out in an uncoated fused silica capillary, 30 cm long × 50 μm internal diameter, using an effective length of 10 cm and a microemulsion composed of octane, butanol, sodium dodecyl sulfate and borate buffer as background electrolyte, a - 500 V x cm(-1) electric field and a detection wavelength of 214 nm.
Artemether, lumefantrine and pyrimethamine were separated in 6 min. The method was reliable with respect to selectivity towards formulation excipients, linearity of the response function (r2 > 0.998), recovery studies from synthetic tablets (in the range 99-101%), repeatability (relative standard deviation 1-3%, n = 7 analytical procedures). Application to four commercial formulations containing 20/120 mg of AL per tablet gave a content in good agreement with the declared content. However, the electropherogram of one tablet formulation showed the presence of an ingredient which was not declared.
The developed MEEKC method can be proposed as an alternative method to liquid chromatography for the determination of artemether and lumefantrine in fixed-dose combination tablet formulations. |
| doi_str_mv | 10.1186/1475-2875-12-202 |
| format | Article |
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Artemether and lumefantrine were determined by microemulsion electrokinetic chromatography using short-end injection procedure. The two analytes were extracted from tablets by acidified methanol. Pyrimethamine was used as internal standard. Separation was carried out in an uncoated fused silica capillary, 30 cm long × 50 μm internal diameter, using an effective length of 10 cm and a microemulsion composed of octane, butanol, sodium dodecyl sulfate and borate buffer as background electrolyte, a - 500 V x cm(-1) electric field and a detection wavelength of 214 nm.
Artemether, lumefantrine and pyrimethamine were separated in 6 min. The method was reliable with respect to selectivity towards formulation excipients, linearity of the response function (r2 > 0.998), recovery studies from synthetic tablets (in the range 99-101%), repeatability (relative standard deviation 1-3%, n = 7 analytical procedures). Application to four commercial formulations containing 20/120 mg of AL per tablet gave a content in good agreement with the declared content. However, the electropherogram of one tablet formulation showed the presence of an ingredient which was not declared.
The developed MEEKC method can be proposed as an alternative method to liquid chromatography for the determination of artemether and lumefantrine in fixed-dose combination tablet formulations.</description><identifier>ISSN: 1475-2875</identifier><identifier>EISSN: 1475-2875</identifier><identifier>DOI: 10.1186/1475-2875-12-202</identifier><identifier>PMID: 23763957</identifier><language>eng</language><publisher>England: BioMed Central Ltd</publisher><subject>Advantages ; Analytical chemistry ; Antimalarials ; Antimalarials - analysis ; Antimalarials - chemistry ; Antimalarials - isolation & purification ; Artemether, Lumefantrine Drug Combination ; Artemisinins - analysis ; Artemisinins - chemistry ; Artemisinins - isolation & purification ; Borates ; Chromatography ; Chromatography, Micellar Electrokinetic Capillary - methods ; Developing countries ; Dosage and administration ; Drug Combinations ; Drug dosages ; Drug therapy ; Electric fields ; Electrolytes ; Emulsions - chemistry ; Ethanolamines - analysis ; Ethanolamines - chemistry ; Ethanolamines - isolation & purification ; Fluorenes - analysis ; Fluorenes - chemistry ; Fluorenes - isolation & purification ; Injection ; LDCs ; Life Sciences ; Limit of Detection ; Linear Models ; Liquid chromatography ; Malaria ; Methods ; Microemulsions ; Operating costs ; Quality control ; Quality management ; Reproducibility of Results ; Silica ; Tablets</subject><ispartof>Malaria journal, 2013-06, Vol.12 (1), p.202-202, Article 202</ispartof><rights>COPYRIGHT 2013 BioMed Central Ltd.</rights><rights>2013 Amin et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</rights><rights>Attribution</rights><rights>Copyright © 2013 Amin et al.; licensee BioMed Central Ltd. 2013 Amin et al.; licensee BioMed Central Ltd.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b618t-72c8a29aaae8171b0af39925cf75ce865698a23f28db20a10c4e92deef00dd473</citedby><cites>FETCH-LOGICAL-b618t-72c8a29aaae8171b0af39925cf75ce865698a23f28db20a10c4e92deef00dd473</cites><orcidid>0000-0003-3102-8666 ; 0000-0003-1250-7821</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3687677/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3687677/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,27903,27904,53769,53771</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23763957$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://hal.science/hal-03564196$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Amin, N'Cho Christophe</creatorcontrib><creatorcontrib>Fabre, Huguette</creatorcontrib><creatorcontrib>Blanchin, Marie-Dominique</creatorcontrib><creatorcontrib>Montels, Jérôme</creatorcontrib><creatorcontrib>Aké, Michèle</creatorcontrib><title>Determination of artemether and lumefantrine in anti-malarial fixed-dose combination tablets by microemulsion electrokinetic chromatography with short-end injection procedure</title><title>Malaria journal</title><addtitle>Malar J</addtitle><description>Artemether-lumefantrine (AL) combination therapy is now the most used anti-malarial treatment in the world. Quality control of AL formulations is still a major challenge in developing countries. Until now, only liquid chromatographic methods have been reported in the literature for their analysis. Capillary electrophoretic methods, which present various advantages (low price of capillary, low volumes of electrolyte consumption), may be an alternative to liquid chromatography methods. In this paper, a reliable method was developed and validated for the determination of AL in commercial fixed-dose combination tablets commercialized in Côte d'Ivoire.
Artemether and lumefantrine were determined by microemulsion electrokinetic chromatography using short-end injection procedure. The two analytes were extracted from tablets by acidified methanol. Pyrimethamine was used as internal standard. Separation was carried out in an uncoated fused silica capillary, 30 cm long × 50 μm internal diameter, using an effective length of 10 cm and a microemulsion composed of octane, butanol, sodium dodecyl sulfate and borate buffer as background electrolyte, a - 500 V x cm(-1) electric field and a detection wavelength of 214 nm.
Artemether, lumefantrine and pyrimethamine were separated in 6 min. The method was reliable with respect to selectivity towards formulation excipients, linearity of the response function (r2 > 0.998), recovery studies from synthetic tablets (in the range 99-101%), repeatability (relative standard deviation 1-3%, n = 7 analytical procedures). Application to four commercial formulations containing 20/120 mg of AL per tablet gave a content in good agreement with the declared content. However, the electropherogram of one tablet formulation showed the presence of an ingredient which was not declared.
The developed MEEKC method can be proposed as an alternative method to liquid chromatography for the determination of artemether and lumefantrine in fixed-dose combination tablet formulations.</description><subject>Advantages</subject><subject>Analytical chemistry</subject><subject>Antimalarials</subject><subject>Antimalarials - analysis</subject><subject>Antimalarials - chemistry</subject><subject>Antimalarials - isolation & purification</subject><subject>Artemether, Lumefantrine Drug Combination</subject><subject>Artemisinins - analysis</subject><subject>Artemisinins - chemistry</subject><subject>Artemisinins - isolation & purification</subject><subject>Borates</subject><subject>Chromatography</subject><subject>Chromatography, Micellar Electrokinetic Capillary - methods</subject><subject>Developing countries</subject><subject>Dosage and administration</subject><subject>Drug Combinations</subject><subject>Drug dosages</subject><subject>Drug therapy</subject><subject>Electric fields</subject><subject>Electrolytes</subject><subject>Emulsions - chemistry</subject><subject>Ethanolamines - analysis</subject><subject>Ethanolamines - chemistry</subject><subject>Ethanolamines - isolation & purification</subject><subject>Fluorenes - analysis</subject><subject>Fluorenes - chemistry</subject><subject>Fluorenes - isolation & purification</subject><subject>Injection</subject><subject>LDCs</subject><subject>Life Sciences</subject><subject>Limit of Detection</subject><subject>Linear Models</subject><subject>Liquid chromatography</subject><subject>Malaria</subject><subject>Methods</subject><subject>Microemulsions</subject><subject>Operating costs</subject><subject>Quality control</subject><subject>Quality management</subject><subject>Reproducibility of Results</subject><subject>Silica</subject><subject>Tablets</subject><issn>1475-2875</issn><issn>1475-2875</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><recordid>eNqFU02P0zAQjRCIXQp3TsgSFzhksZ0PJxekqnwsUiUucLYcZ9K4JHaxnV36p_iNTNTdsl0tQpESa-a9N9Z7kyR5yegFY1X5juWiSHmFL8ZTTvmj5PxYenznfJY8C2FLKROV4E-TM56JMqsLcZ78_gAR_GisisZZ4jqifIQRYg-eKNuSYRqhUzZ6Y4EYi7Vo0lENyhs1kM78gjZtXQCi3djcykTVDBADafZkNNo7GKchzA0YQEfvfqBYNJro3rtRRbfxatfvybWJPQm98zEFHG3sFtEzbeedhnby8Dx50qkhwIub7yL5_unjt9Vluv76-ctquU6bklUxFVxXitdKKaiYYA1VXVbXvNCdKDRUZVHW2M86XrUNp4pRnUPNW4CO0rbNRbZI3h90d1MzQqsBDVCD3HkzKr-XThl52rGmlxt3JbOyEqWYBd4eBPp7tMvlWs41mhVlzuryiiF2dcA2xv1j2GkHrZZztnLOVjIuMXpUeXNzZe9-ThCiHE3QMAzKgpuCZEVeYeiI_D8UzapZIYoKoa_vQbdu8ha9R5RglNGsZn9RGzWANLZzeE89i8plkeVlkQmcvUguHkDh0wJuibPQGayfEOiBgCsUgofu6Amjcv4BHnLh1d3gjoTbjc_-AK_jBO8</recordid><startdate>20130613</startdate><enddate>20130613</enddate><creator>Amin, N'Cho Christophe</creator><creator>Fabre, Huguette</creator><creator>Blanchin, Marie-Dominique</creator><creator>Montels, Jérôme</creator><creator>Aké, Michèle</creator><general>BioMed Central Ltd</general><general>BioMed Central</general><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>3V.</scope><scope>7SS</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8C1</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AEUYN</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>C1K</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>F1W</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>H95</scope><scope>H97</scope><scope>K9.</scope><scope>L.G</scope><scope>M0S</scope><scope>M1P</scope><scope>M7N</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>7X8</scope><scope>1XC</scope><scope>VOOES</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0003-3102-8666</orcidid><orcidid>https://orcid.org/0000-0003-1250-7821</orcidid></search><sort><creationdate>20130613</creationdate><title>Determination of artemether and lumefantrine in anti-malarial fixed-dose combination tablets by microemulsion electrokinetic chromatography with short-end injection procedure</title><author>Amin, N'Cho Christophe ; Fabre, Huguette ; Blanchin, Marie-Dominique ; Montels, Jérôme ; Aké, Michèle</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b618t-72c8a29aaae8171b0af39925cf75ce865698a23f28db20a10c4e92deef00dd473</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Advantages</topic><topic>Analytical chemistry</topic><topic>Antimalarials</topic><topic>Antimalarials - analysis</topic><topic>Antimalarials - chemistry</topic><topic>Antimalarials - isolation & purification</topic><topic>Artemether, Lumefantrine Drug Combination</topic><topic>Artemisinins - analysis</topic><topic>Artemisinins - chemistry</topic><topic>Artemisinins - isolation & purification</topic><topic>Borates</topic><topic>Chromatography</topic><topic>Chromatography, Micellar Electrokinetic Capillary - methods</topic><topic>Developing countries</topic><topic>Dosage and administration</topic><topic>Drug Combinations</topic><topic>Drug dosages</topic><topic>Drug therapy</topic><topic>Electric fields</topic><topic>Electrolytes</topic><topic>Emulsions - chemistry</topic><topic>Ethanolamines - analysis</topic><topic>Ethanolamines - chemistry</topic><topic>Ethanolamines - isolation & purification</topic><topic>Fluorenes - analysis</topic><topic>Fluorenes - chemistry</topic><topic>Fluorenes - isolation & purification</topic><topic>Injection</topic><topic>LDCs</topic><topic>Life Sciences</topic><topic>Limit of Detection</topic><topic>Linear Models</topic><topic>Liquid chromatography</topic><topic>Malaria</topic><topic>Methods</topic><topic>Microemulsions</topic><topic>Operating costs</topic><topic>Quality control</topic><topic>Quality management</topic><topic>Reproducibility of Results</topic><topic>Silica</topic><topic>Tablets</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Amin, N'Cho Christophe</creatorcontrib><creatorcontrib>Fabre, Huguette</creatorcontrib><creatorcontrib>Blanchin, Marie-Dominique</creatorcontrib><creatorcontrib>Montels, Jérôme</creatorcontrib><creatorcontrib>Aké, Michèle</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Entomology Abstracts (Full archive)</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Public Health Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest One Sustainability</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>ASFA: Aquatic Sciences and Fisheries Abstracts</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>Aquatic Science & Fisheries Abstracts (ASFA) 1: Biological Sciences & Living Resources</collection><collection>Aquatic Science & Fisheries Abstracts (ASFA) 3: Aquatic Pollution & Environmental Quality</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Aquatic Science & Fisheries Abstracts (ASFA) Professional</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>MEDLINE - Academic</collection><collection>Hyper Article en Ligne (HAL)</collection><collection>Hyper Article en Ligne (HAL) (Open Access)</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Malaria journal</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Amin, N'Cho Christophe</au><au>Fabre, Huguette</au><au>Blanchin, Marie-Dominique</au><au>Montels, Jérôme</au><au>Aké, Michèle</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Determination of artemether and lumefantrine in anti-malarial fixed-dose combination tablets by microemulsion electrokinetic chromatography with short-end injection procedure</atitle><jtitle>Malaria journal</jtitle><addtitle>Malar J</addtitle><date>2013-06-13</date><risdate>2013</risdate><volume>12</volume><issue>1</issue><spage>202</spage><epage>202</epage><pages>202-202</pages><artnum>202</artnum><issn>1475-2875</issn><eissn>1475-2875</eissn><abstract>Artemether-lumefantrine (AL) combination therapy is now the most used anti-malarial treatment in the world. Quality control of AL formulations is still a major challenge in developing countries. Until now, only liquid chromatographic methods have been reported in the literature for their analysis. Capillary electrophoretic methods, which present various advantages (low price of capillary, low volumes of electrolyte consumption), may be an alternative to liquid chromatography methods. In this paper, a reliable method was developed and validated for the determination of AL in commercial fixed-dose combination tablets commercialized in Côte d'Ivoire.
Artemether and lumefantrine were determined by microemulsion electrokinetic chromatography using short-end injection procedure. The two analytes were extracted from tablets by acidified methanol. Pyrimethamine was used as internal standard. Separation was carried out in an uncoated fused silica capillary, 30 cm long × 50 μm internal diameter, using an effective length of 10 cm and a microemulsion composed of octane, butanol, sodium dodecyl sulfate and borate buffer as background electrolyte, a - 500 V x cm(-1) electric field and a detection wavelength of 214 nm.
Artemether, lumefantrine and pyrimethamine were separated in 6 min. The method was reliable with respect to selectivity towards formulation excipients, linearity of the response function (r2 > 0.998), recovery studies from synthetic tablets (in the range 99-101%), repeatability (relative standard deviation 1-3%, n = 7 analytical procedures). Application to four commercial formulations containing 20/120 mg of AL per tablet gave a content in good agreement with the declared content. However, the electropherogram of one tablet formulation showed the presence of an ingredient which was not declared.
The developed MEEKC method can be proposed as an alternative method to liquid chromatography for the determination of artemether and lumefantrine in fixed-dose combination tablet formulations.</abstract><cop>England</cop><pub>BioMed Central Ltd</pub><pmid>23763957</pmid><doi>10.1186/1475-2875-12-202</doi><tpages>1</tpages><orcidid>https://orcid.org/0000-0003-3102-8666</orcidid><orcidid>https://orcid.org/0000-0003-1250-7821</orcidid><oa>free_for_read</oa></addata></record> |
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| ispartof | Malaria journal, 2013-06, Vol.12 (1), p.202-202, Article 202 |
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| subjects | Advantages Analytical chemistry Antimalarials Antimalarials - analysis Antimalarials - chemistry Antimalarials - isolation & purification Artemether, Lumefantrine Drug Combination Artemisinins - analysis Artemisinins - chemistry Artemisinins - isolation & purification Borates Chromatography Chromatography, Micellar Electrokinetic Capillary - methods Developing countries Dosage and administration Drug Combinations Drug dosages Drug therapy Electric fields Electrolytes Emulsions - chemistry Ethanolamines - analysis Ethanolamines - chemistry Ethanolamines - isolation & purification Fluorenes - analysis Fluorenes - chemistry Fluorenes - isolation & purification Injection LDCs Life Sciences Limit of Detection Linear Models Liquid chromatography Malaria Methods Microemulsions Operating costs Quality control Quality management Reproducibility of Results Silica Tablets |
| title | Determination of artemether and lumefantrine in anti-malarial fixed-dose combination tablets by microemulsion electrokinetic chromatography with short-end injection procedure |
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