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Rapid Turbidimetric Assay to Determine the Potency of Daptomycin in Lyophilized Powder

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 antimicr...

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Autores principales: Tótoli, Eliane Gandolpho, Salgado, Hérida Regina Nunes
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4588188/
https://www.ncbi.nlm.nih.gov/pubmed/26184288
http://dx.doi.org/10.3390/pharmaceutics7030106
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author Tótoli, Eliane Gandolpho
Salgado, Hérida Regina Nunes
author_facet Tótoli, Eliane Gandolpho
Salgado, Hérida Regina Nunes
author_sort Tótoli, Eliane Gandolpho
collection PubMed
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.
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spelling pubmed-45881882015-10-08 Rapid Turbidimetric Assay to Determine the Potency of Daptomycin in Lyophilized Powder Tótoli, Eliane Gandolpho Salgado, Hérida Regina Nunes Pharmaceutics Article 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. MDPI 2015-07-09 /pmc/articles/PMC4588188/ /pubmed/26184288 http://dx.doi.org/10.3390/pharmaceutics7030106 Text en © 2015 by the authors; licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Tótoli, Eliane Gandolpho
Salgado, Hérida Regina Nunes
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
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_short 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
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4588188/
https://www.ncbi.nlm.nih.gov/pubmed/26184288
http://dx.doi.org/10.3390/pharmaceutics7030106
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