Miniaturized Microbiological Method to Determine the Potency of Rifaximin in Tablets
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/qsab017 http://hdl.handle.net/11449/229694 |
Resumo: | BACKGROUND: Rifaximin, a semi-synthetic antimicrobial, does not present microbiological method described in official compendia, and there is a lack of literature on this topic. The quality control of antimicrobials is extremely important to evaluate the real potency of pharmaceutical products. OBJECTIVE: A miniaturized turbidimetric method for determining the potency of rifaximin in tablets was developed and validated by turbidimetry, according to the international guidelines. METHOD: Escherichia coli ATCC 10536 IAL 2393, brain heart infusion (BHI) broth, inoculum at 8%, rifaximin in purified water with 20% ethanol at 5, 10, and 20 μg/mL and 530 nm were used. RESULTS: The method was considered selective for rifaximin, as the adjuvants did not show activity; linear with correlation coefficients 0.9998 for standard and 0.9999 for sample; accurate with 99.73% recovery; precise with RSD less than 3%; and robust in the face of small variations in (i) rifaximin volume, (ii) proportion of ethanol, (iii) inoculum volume. CONCLUSIONS: The method is considered adequate and safe to evaluate the potency of rifaximin in tablets, contemplating speed, low cost, low waste generation, and ease of operation. HIGHLIGHTS: This work usescurrent, sustainable, and green analytical chemistry and can be used in the routine analyses of rifaximin by laboratories and the pharmaceutical industry around the world. |
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Miniaturized Microbiological Method to Determine the Potency of Rifaximin in TabletsBACKGROUND: Rifaximin, a semi-synthetic antimicrobial, does not present microbiological method described in official compendia, and there is a lack of literature on this topic. The quality control of antimicrobials is extremely important to evaluate the real potency of pharmaceutical products. OBJECTIVE: A miniaturized turbidimetric method for determining the potency of rifaximin in tablets was developed and validated by turbidimetry, according to the international guidelines. METHOD: Escherichia coli ATCC 10536 IAL 2393, brain heart infusion (BHI) broth, inoculum at 8%, rifaximin in purified water with 20% ethanol at 5, 10, and 20 μg/mL and 530 nm were used. RESULTS: The method was considered selective for rifaximin, as the adjuvants did not show activity; linear with correlation coefficients 0.9998 for standard and 0.9999 for sample; accurate with 99.73% recovery; precise with RSD less than 3%; and robust in the face of small variations in (i) rifaximin volume, (ii) proportion of ethanol, (iii) inoculum volume. CONCLUSIONS: The method is considered adequate and safe to evaluate the potency of rifaximin in tablets, contemplating speed, low cost, low waste generation, and ease of operation. HIGHLIGHTS: This work usescurrent, sustainable, and green analytical chemistry and can be used in the routine analyses of rifaximin by laboratories and the pharmaceutical industry around the world.Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)São Paulo State University School of Pharmaceutical Sciences Department of Drugs and MedicinesUniversidade Federal de Goiás Faculdade de Farmácia Laboratório de Controle de QualidadeSão Paulo State University School of Pharmaceutical Sciences Department of Drugs and MedicinesUniversidade Estadual Paulista (UNESP)Universidade Federal de Goiás (UFG)Correa, Clara Bersi Motta [UNESP]Kogawa, Ana CarolinaChorilli, Marlus [UNESP]Salgado, Hérida Regina Nunes [UNESP]2022-04-29T08:35:08Z2022-04-29T08:35:08Z2021-08-20info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/article1049-1054http://dx.doi.org/10.1093/jaoacint/qsab017Journal of AOAC International, v. 104, n. 4, p. 1049-1054, 2021.1944-7922http://hdl.handle.net/11449/22969410.1093/jaoacint/qsab0172-s2.0-85116957471Scopusreponame:Repositório Institucional da UNESPinstname:Universidade Estadual Paulista (UNESP)instacron:UNESPengJournal of AOAC Internationalinfo:eu-repo/semantics/openAccess2024-06-24T13:45:06Zoai:repositorio.unesp.br:11449/229694Repositório InstitucionalPUBhttp://repositorio.unesp.br/oai/requestopendoar:29462024-08-05T14:44:28.058217Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)false |
dc.title.none.fl_str_mv |
Miniaturized Microbiological Method to Determine the Potency of Rifaximin in Tablets |
title |
Miniaturized Microbiological Method to Determine the Potency of Rifaximin in Tablets |
spellingShingle |
Miniaturized Microbiological Method to Determine the Potency of Rifaximin in Tablets Correa, Clara Bersi Motta [UNESP] |
title_short |
Miniaturized Microbiological Method to Determine the Potency of Rifaximin in Tablets |
title_full |
Miniaturized Microbiological Method to Determine the Potency of Rifaximin in Tablets |
title_fullStr |
Miniaturized Microbiological Method to Determine the Potency of Rifaximin in Tablets |
title_full_unstemmed |
Miniaturized Microbiological Method to Determine the Potency of Rifaximin in Tablets |
title_sort |
Miniaturized Microbiological Method to Determine the Potency of Rifaximin in Tablets |
author |
Correa, Clara Bersi Motta [UNESP] |
author_facet |
Correa, Clara Bersi Motta [UNESP] Kogawa, Ana Carolina Chorilli, Marlus [UNESP] Salgado, Hérida Regina Nunes [UNESP] |
author_role |
author |
author2 |
Kogawa, Ana Carolina Chorilli, Marlus [UNESP] Salgado, Hérida Regina Nunes [UNESP] |
author2_role |
author author author |
dc.contributor.none.fl_str_mv |
Universidade Estadual Paulista (UNESP) Universidade Federal de Goiás (UFG) |
dc.contributor.author.fl_str_mv |
Correa, Clara Bersi Motta [UNESP] Kogawa, Ana Carolina Chorilli, Marlus [UNESP] Salgado, Hérida Regina Nunes [UNESP] |
description |
BACKGROUND: Rifaximin, a semi-synthetic antimicrobial, does not present microbiological method described in official compendia, and there is a lack of literature on this topic. The quality control of antimicrobials is extremely important to evaluate the real potency of pharmaceutical products. OBJECTIVE: A miniaturized turbidimetric method for determining the potency of rifaximin in tablets was developed and validated by turbidimetry, according to the international guidelines. METHOD: Escherichia coli ATCC 10536 IAL 2393, brain heart infusion (BHI) broth, inoculum at 8%, rifaximin in purified water with 20% ethanol at 5, 10, and 20 μg/mL and 530 nm were used. RESULTS: The method was considered selective for rifaximin, as the adjuvants did not show activity; linear with correlation coefficients 0.9998 for standard and 0.9999 for sample; accurate with 99.73% recovery; precise with RSD less than 3%; and robust in the face of small variations in (i) rifaximin volume, (ii) proportion of ethanol, (iii) inoculum volume. CONCLUSIONS: The method is considered adequate and safe to evaluate the potency of rifaximin in tablets, contemplating speed, low cost, low waste generation, and ease of operation. HIGHLIGHTS: This work usescurrent, sustainable, and green analytical chemistry and can be used in the routine analyses of rifaximin by laboratories and the pharmaceutical industry around the world. |
publishDate |
2021 |
dc.date.none.fl_str_mv |
2021-08-20 2022-04-29T08:35:08Z 2022-04-29T08:35:08Z |
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/qsab017 Journal of AOAC International, v. 104, n. 4, p. 1049-1054, 2021. 1944-7922 http://hdl.handle.net/11449/229694 10.1093/jaoacint/qsab017 2-s2.0-85116957471 |
url |
http://dx.doi.org/10.1093/jaoacint/qsab017 http://hdl.handle.net/11449/229694 |
identifier_str_mv |
Journal of AOAC International, v. 104, n. 4, p. 1049-1054, 2021. 1944-7922 10.1093/jaoacint/qsab017 2-s2.0-85116957471 |
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 |
1049-1054 |
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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1808128412909305856 |