Rapid turbidimetric assay to determine the potency of daptomycin in lyophilized powder
Autor(a) principal: | |
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Data de Publicação: | 2015 |
Outros Autores: | |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Institucional da UNESP |
Texto Completo: | http://dx.doi.org/10.3390/pharmaceutics7030106 http://hdl.handle.net/11449/131470 |
Resumo: | Daptomycin is an important antimicrobial for clinical practice, mainly because it remains very active against Gram-positive resistant strains, such as methicillin-resistant Staphylococcus aureus and vancomycin-resistant enterococci. Development of microbiological methods for the analysis of antimicrobials is highly recommended, since they can provide important information about their biological activities, which physicochemical methods are not able to provide. Considering that there are no studies in the literature describing microbiological methods for the analysis of daptomycin, the aim of this work was to validate a microbiological method for the quantitation of daptomycin by the turbidimetric assay. Staphylococcus aureus was used as the test microorganism, and the brain heart infusion broth was used as the culture medium. The validation of the method was performed according to the ICH guidelines, and it was shown to be linear, precise, robust, accurate and selective, over a concentration range of 8.0 to 18.0 µg mL-1. Student's t-test showed the interchangeability of the proposed method with a previously-validated HPLC method. The developed turbidimetric method described in this paper is a convenient alternative for the routine quality control of daptomycin in its pharmaceutical dosage form. |
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Rapid turbidimetric assay to determine the potency of daptomycin in lyophilized powderAnalytical methodDaptomycinMicrobiological methodNew antimicrobial agentQuality controlTurbidimetric assayDaptomycin is an important antimicrobial for clinical practice, mainly because it remains very active against Gram-positive resistant strains, such as methicillin-resistant Staphylococcus aureus and vancomycin-resistant enterococci. Development of microbiological methods for the analysis of antimicrobials is highly recommended, since they can provide important information about their biological activities, which physicochemical methods are not able to provide. Considering that there are no studies in the literature describing microbiological methods for the analysis of daptomycin, the aim of this work was to validate a microbiological method for the quantitation of daptomycin by the turbidimetric assay. Staphylococcus aureus was used as the test microorganism, and the brain heart infusion broth was used as the culture medium. The validation of the method was performed according to the ICH guidelines, and it was shown to be linear, precise, robust, accurate and selective, over a concentration range of 8.0 to 18.0 µg mL-1. Student's t-test showed the interchangeability of the proposed method with a previously-validated HPLC method. The developed turbidimetric method described in this paper is a convenient alternative for the routine quality control of daptomycin in its pharmaceutical dosage form.Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)Fundação para o Desenvolvimento da Unesp (FUNDUNESP)Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)School of Pharmaceutical Sciences, Universidade Estadual Paulista, Rod. Araraquara-Jaú, km 1, CEP 14801-902 Araraquara, SP, BrazilSchool of Pharmaceutical Sciences, Universidade Estadual Paulista, Rod. Araraquara-Jaú, km 1, CEP 14801-902 Araraquara, SP, BrazilSchool of Pharmaceutical Sciences, Universidade Estadual Paulista, Rod. Araraquara-Jaú, km 1, CEP 14801-902 Araraquara, SP, BrazilSchool of Pharmaceutical Sciences, Universidade Estadual Paulista, Rod. Araraquara-Jaú, km 1, CEP 14801-902 Araraquara, SP, BrazilUniversidade Estadual Paulista (Unesp)Tótoli, Eliane Gandolpho [UNESP]Salgado, Hérida Regina Nunes [UNESP]2015-12-07T15:36:02Z2015-12-07T15:36:02Z2015info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/article106-121application/pdfhttp://dx.doi.org/10.3390/pharmaceutics7030106Pharmaceutics, v. 7, n. 3, p. 106-121, 2015.1999-4923http://hdl.handle.net/11449/13147010.3390/pharmaceutics7030106PMC4588188.pdf26184288PMC4588188PubMedreponame:Repositório Institucional da UNESPinstname:Universidade Estadual Paulista (UNESP)instacron:UNESPengPharmaceutics3.7460,949info:eu-repo/semantics/openAccess2024-06-24T13:46:11Zoai:repositorio.unesp.br:11449/131470Repositório InstitucionalPUBhttp://repositorio.unesp.br/oai/requestopendoar:29462024-08-05T21:00:01.922288Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)false |
dc.title.none.fl_str_mv |
Rapid turbidimetric assay to determine the potency of daptomycin in lyophilized powder |
title |
Rapid turbidimetric assay to determine the potency of daptomycin in lyophilized powder |
spellingShingle |
Rapid turbidimetric assay to determine the potency of daptomycin in lyophilized powder Tótoli, Eliane Gandolpho [UNESP] Analytical method Daptomycin Microbiological method New antimicrobial agent Quality control Turbidimetric assay |
title_short |
Rapid turbidimetric assay to determine the potency of daptomycin in lyophilized powder |
title_full |
Rapid turbidimetric assay to determine the potency of daptomycin in lyophilized powder |
title_fullStr |
Rapid turbidimetric assay to determine the potency of daptomycin in lyophilized powder |
title_full_unstemmed |
Rapid turbidimetric assay to determine the potency of daptomycin in lyophilized powder |
title_sort |
Rapid turbidimetric assay to determine the potency of daptomycin in lyophilized powder |
author |
Tótoli, Eliane Gandolpho [UNESP] |
author_facet |
Tótoli, Eliane Gandolpho [UNESP] Salgado, Hérida Regina Nunes [UNESP] |
author_role |
author |
author2 |
Salgado, Hérida Regina Nunes [UNESP] |
author2_role |
author |
dc.contributor.none.fl_str_mv |
Universidade Estadual Paulista (Unesp) |
dc.contributor.author.fl_str_mv |
Tótoli, Eliane Gandolpho [UNESP] Salgado, Hérida Regina Nunes [UNESP] |
dc.subject.por.fl_str_mv |
Analytical method Daptomycin Microbiological method New antimicrobial agent Quality control Turbidimetric assay |
topic |
Analytical method Daptomycin Microbiological method New antimicrobial agent Quality control Turbidimetric assay |
description |
Daptomycin is an important antimicrobial for clinical practice, mainly because it remains very active against Gram-positive resistant strains, such as methicillin-resistant Staphylococcus aureus and vancomycin-resistant enterococci. Development of microbiological methods for the analysis of antimicrobials is highly recommended, since they can provide important information about their biological activities, which physicochemical methods are not able to provide. Considering that there are no studies in the literature describing microbiological methods for the analysis of daptomycin, the aim of this work was to validate a microbiological method for the quantitation of daptomycin by the turbidimetric assay. Staphylococcus aureus was used as the test microorganism, and the brain heart infusion broth was used as the culture medium. The validation of the method was performed according to the ICH guidelines, and it was shown to be linear, precise, robust, accurate and selective, over a concentration range of 8.0 to 18.0 µg mL-1. Student's t-test showed the interchangeability of the proposed method with a previously-validated HPLC method. The developed turbidimetric method described in this paper is a convenient alternative for the routine quality control of daptomycin in its pharmaceutical dosage form. |
publishDate |
2015 |
dc.date.none.fl_str_mv |
2015-12-07T15:36:02Z 2015-12-07T15:36:02Z 2015 |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://dx.doi.org/10.3390/pharmaceutics7030106 Pharmaceutics, v. 7, n. 3, p. 106-121, 2015. 1999-4923 http://hdl.handle.net/11449/131470 10.3390/pharmaceutics7030106 PMC4588188.pdf 26184288 PMC4588188 |
url |
http://dx.doi.org/10.3390/pharmaceutics7030106 http://hdl.handle.net/11449/131470 |
identifier_str_mv |
Pharmaceutics, v. 7, n. 3, p. 106-121, 2015. 1999-4923 10.3390/pharmaceutics7030106 PMC4588188.pdf 26184288 PMC4588188 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
Pharmaceutics 3.746 0,949 |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
106-121 application/pdf |
dc.source.none.fl_str_mv |
PubMed reponame:Repositório Institucional da UNESP instname:Universidade Estadual Paulista (UNESP) instacron:UNESP |
instname_str |
Universidade Estadual Paulista (UNESP) |
instacron_str |
UNESP |
institution |
UNESP |
reponame_str |
Repositório Institucional da UNESP |
collection |
Repositório Institucional da UNESP |
repository.name.fl_str_mv |
Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP) |
repository.mail.fl_str_mv |
|
_version_ |
1808129271775887360 |