Turbidimetric Method: A Multi-Advantageous Option for Assessing the Potency of Ceftriaxone Sodium in Powder for Injection
Autor(a) principal: | |
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Data de Publicação: | 2021 |
Outros Autores: | , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Institucional da UNESP |
Texto Completo: | http://dx.doi.org/10.1093/jaoacint/qsaa085 http://hdl.handle.net/11449/207547 |
Resumo: | BACKGROUND: Ceftriaxone sodium, an antimicrobial used in parenteral form, does not have a microbiological method by turbidimetry described in the literature. For drugs from antimicrobial class, the existence of a microbiological method for assessing their potency is essential. Not only are the results from the physical-chemical methods enough, but microbiological analyzes are also necessary. OBJECTIVE AND METHODS: Thus, this paper reports the development and validation of an efficient, accurate, reproducible, fast, and low-cost microbiological assay by turbidimetry to quantify ceftriaxone sodium in powder for injection. Water was used as the diluent to prepare the ceftriaxone solutions. BHI broth as used as culture media for the growth of the S. aureus ATCC 6538 at 9%. RESULTS: The method was linear in the range of 100-196 µg/mL, selective against the sample adjuvants and the forced degradation test, precise (intraday RSD 4.53%, interday RSD 3.85% and between analysts tcalculated 0.14 < 2.23 tcritical), accurate with recovery of 100.33% and robust against minor changes in the volume of culture medium used, wavelength, incubation time, and inoculum concentration. CONCLUSIONS AND HIGHLIGHTS: The turbidimetric method developed in this paper is a convenient and valuable alternative to the routine quality control of ceftriaxone sodium in powder for injection, since it allows a reliable quantification and can be used to complement the physical-chemical analysis. |
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Turbidimetric Method: A Multi-Advantageous Option for Assessing the Potency of Ceftriaxone Sodium in Powder for InjectionBACKGROUND: Ceftriaxone sodium, an antimicrobial used in parenteral form, does not have a microbiological method by turbidimetry described in the literature. For drugs from antimicrobial class, the existence of a microbiological method for assessing their potency is essential. Not only are the results from the physical-chemical methods enough, but microbiological analyzes are also necessary. OBJECTIVE AND METHODS: Thus, this paper reports the development and validation of an efficient, accurate, reproducible, fast, and low-cost microbiological assay by turbidimetry to quantify ceftriaxone sodium in powder for injection. Water was used as the diluent to prepare the ceftriaxone solutions. BHI broth as used as culture media for the growth of the S. aureus ATCC 6538 at 9%. RESULTS: The method was linear in the range of 100-196 µg/mL, selective against the sample adjuvants and the forced degradation test, precise (intraday RSD 4.53%, interday RSD 3.85% and between analysts tcalculated 0.14 < 2.23 tcritical), accurate with recovery of 100.33% and robust against minor changes in the volume of culture medium used, wavelength, incubation time, and inoculum concentration. CONCLUSIONS AND HIGHLIGHTS: The turbidimetric method developed in this paper is a convenient and valuable alternative to the routine quality control of ceftriaxone sodium in powder for injection, since it allows a reliable quantification and can be used to complement the physical-chemical analysis.Departamento de Fármacos e Medicamentos Faculdade de Ciências Farmacêuticas de Araraquara Universidade Estadual Paulista-UNESPLaboratório de Controle de Qualidade Faculdade de Farmácia Universidade Federal de GoiásDepartamento de Fármacos e Medicamentos Faculdade de Ciências Farmacêuticas de Araraquara Universidade Estadual Paulista-UNESPUniversidade Estadual Paulista (Unesp)Universidade Federal de Goiás (UFG)da Trindade, Mariana Teixeira [UNESP]Kogawa, Ana CarolinaSalgado, Hérida Regina Nunes [UNESP]2021-06-25T10:57:05Z2021-06-25T10:57:05Z2021-03-05info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/article204-210http://dx.doi.org/10.1093/jaoacint/qsaa085Journal of AOAC International, v. 104, n. 1, p. 204-210, 2021.1944-7922http://hdl.handle.net/11449/20754710.1093/jaoacint/qsaa0852-s2.0-85103474083Scopusreponame:Repositório Institucional da UNESPinstname:Universidade Estadual Paulista (UNESP)instacron:UNESPengJournal of AOAC Internationalinfo:eu-repo/semantics/openAccess2024-06-24T13:46:00Zoai:repositorio.unesp.br:11449/207547Repositório InstitucionalPUBhttp://repositorio.unesp.br/oai/requestopendoar:29462024-08-05T19:40:20.738181Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)false |
dc.title.none.fl_str_mv |
Turbidimetric Method: A Multi-Advantageous Option for Assessing the Potency of Ceftriaxone Sodium in Powder for Injection |
title |
Turbidimetric Method: A Multi-Advantageous Option for Assessing the Potency of Ceftriaxone Sodium in Powder for Injection |
spellingShingle |
Turbidimetric Method: A Multi-Advantageous Option for Assessing the Potency of Ceftriaxone Sodium in Powder for Injection da Trindade, Mariana Teixeira [UNESP] |
title_short |
Turbidimetric Method: A Multi-Advantageous Option for Assessing the Potency of Ceftriaxone Sodium in Powder for Injection |
title_full |
Turbidimetric Method: A Multi-Advantageous Option for Assessing the Potency of Ceftriaxone Sodium in Powder for Injection |
title_fullStr |
Turbidimetric Method: A Multi-Advantageous Option for Assessing the Potency of Ceftriaxone Sodium in Powder for Injection |
title_full_unstemmed |
Turbidimetric Method: A Multi-Advantageous Option for Assessing the Potency of Ceftriaxone Sodium in Powder for Injection |
title_sort |
Turbidimetric Method: A Multi-Advantageous Option for Assessing the Potency of Ceftriaxone Sodium in Powder for Injection |
author |
da Trindade, Mariana Teixeira [UNESP] |
author_facet |
da Trindade, Mariana Teixeira [UNESP] Kogawa, Ana Carolina Salgado, Hérida Regina Nunes [UNESP] |
author_role |
author |
author2 |
Kogawa, Ana Carolina Salgado, Hérida Regina Nunes [UNESP] |
author2_role |
author author |
dc.contributor.none.fl_str_mv |
Universidade Estadual Paulista (Unesp) Universidade Federal de Goiás (UFG) |
dc.contributor.author.fl_str_mv |
da Trindade, Mariana Teixeira [UNESP] Kogawa, Ana Carolina Salgado, Hérida Regina Nunes [UNESP] |
description |
BACKGROUND: Ceftriaxone sodium, an antimicrobial used in parenteral form, does not have a microbiological method by turbidimetry described in the literature. For drugs from antimicrobial class, the existence of a microbiological method for assessing their potency is essential. Not only are the results from the physical-chemical methods enough, but microbiological analyzes are also necessary. OBJECTIVE AND METHODS: Thus, this paper reports the development and validation of an efficient, accurate, reproducible, fast, and low-cost microbiological assay by turbidimetry to quantify ceftriaxone sodium in powder for injection. Water was used as the diluent to prepare the ceftriaxone solutions. BHI broth as used as culture media for the growth of the S. aureus ATCC 6538 at 9%. RESULTS: The method was linear in the range of 100-196 µg/mL, selective against the sample adjuvants and the forced degradation test, precise (intraday RSD 4.53%, interday RSD 3.85% and between analysts tcalculated 0.14 < 2.23 tcritical), accurate with recovery of 100.33% and robust against minor changes in the volume of culture medium used, wavelength, incubation time, and inoculum concentration. CONCLUSIONS AND HIGHLIGHTS: The turbidimetric method developed in this paper is a convenient and valuable alternative to the routine quality control of ceftriaxone sodium in powder for injection, since it allows a reliable quantification and can be used to complement the physical-chemical analysis. |
publishDate |
2021 |
dc.date.none.fl_str_mv |
2021-06-25T10:57:05Z 2021-06-25T10:57:05Z 2021-03-05 |
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/10.1093/jaoacint/qsaa085 Journal of AOAC International, v. 104, n. 1, p. 204-210, 2021. 1944-7922 http://hdl.handle.net/11449/207547 10.1093/jaoacint/qsaa085 2-s2.0-85103474083 |
url |
http://dx.doi.org/10.1093/jaoacint/qsaa085 http://hdl.handle.net/11449/207547 |
identifier_str_mv |
Journal of AOAC International, v. 104, n. 1, p. 204-210, 2021. 1944-7922 10.1093/jaoacint/qsaa085 2-s2.0-85103474083 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
Journal of AOAC International |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
204-210 |
dc.source.none.fl_str_mv |
Scopus 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 |
|
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1808129105037623296 |