Miniaturized turbidimetric assay: A green option for the analysis of besifloxacin in ophthalmic suspension
Autor(a) principal: | |
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Data de Publicação: | 2020 |
Outros Autores: | |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Institucional da UNESP |
Texto Completo: | http://dx.doi.org/10.1016/j.talanta.2019.120532 http://hdl.handle.net/11449/201348 |
Resumo: | Besifloxacin is an important antimicrobial agent, belonging to the class of fluoroquinolones, used in the treatment of infectious conjunctivitis. Quality control of this active pharmaceutical ingredient is essential, since poor quality antimicrobials may contribute to the aggravation of the worrying picture of bacterial resistance. Thus, analytical methods need to be developed, validated and improved for that purpose. It is also important that these methods be environmentally friendly, as ensuring the quality of products without harming the environment meets the global needs. The aim of the study was the development and validation of a miniaturized turbidimetric microbiological method for the analysis of besifloxacin hydrochloride (BSF) in ophthalmic suspension. The analyzes were performed in 96-well microplates using Staphylococcus epidermidis ATCC 12228 as test microorganism and BHI broth. The method was validated according to ICH guidelines and showed to be linear (in a range of 0.5–8.0 μg mL−1), precise, accurate, robust and selective. Study of photo-degradation kinetics of BSF sample showed a zero order reaction. A comparative study with a previously validated HPLC method showed that the methods are interchangeable. This work shows the great potential of the proposed method of being introduced in routine analyzes of quality control of BSF in ophthalmic suspension as an option in line with the principles of Green Chemistry. |
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Miniaturized turbidimetric assay: A green option for the analysis of besifloxacin in ophthalmic suspensionBesifloxacinGreen chemistryMiniaturized turbidimetric assayQuality controlValidationBesifloxacin is an important antimicrobial agent, belonging to the class of fluoroquinolones, used in the treatment of infectious conjunctivitis. Quality control of this active pharmaceutical ingredient is essential, since poor quality antimicrobials may contribute to the aggravation of the worrying picture of bacterial resistance. Thus, analytical methods need to be developed, validated and improved for that purpose. It is also important that these methods be environmentally friendly, as ensuring the quality of products without harming the environment meets the global needs. The aim of the study was the development and validation of a miniaturized turbidimetric microbiological method for the analysis of besifloxacin hydrochloride (BSF) in ophthalmic suspension. The analyzes were performed in 96-well microplates using Staphylococcus epidermidis ATCC 12228 as test microorganism and BHI broth. The method was validated according to ICH guidelines and showed to be linear (in a range of 0.5–8.0 μg mL−1), precise, accurate, robust and selective. Study of photo-degradation kinetics of BSF sample showed a zero order reaction. A comparative study with a previously validated HPLC method showed that the methods are interchangeable. This work shows the great potential of the proposed method of being introduced in routine analyzes of quality control of BSF in ophthalmic suspension as an option in line with the principles of Green Chemistry.Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)School of Pharmaceutical Sciences UNESP - Universidade Estadual PaulistaSchool of Pharmaceutical Sciences UNESP - Universidade Estadual PaulistaCNPq: 150139/2017-9Universidade Estadual Paulista (Unesp)Tótoli, Eliane Gandolpho [UNESP]Salgado, Hérida Regina Nunes [UNESP]2020-12-12T02:30:13Z2020-12-12T02:30:13Z2020-03-01info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articlehttp://dx.doi.org/10.1016/j.talanta.2019.120532Talanta, v. 209.0039-9140http://hdl.handle.net/11449/20134810.1016/j.talanta.2019.1205322-s2.0-85075493489Scopusreponame:Repositório Institucional da UNESPinstname:Universidade Estadual Paulista (UNESP)instacron:UNESPengTalantainfo:eu-repo/semantics/openAccess2024-06-24T13:45:29Zoai:repositorio.unesp.br:11449/201348Repositório InstitucionalPUBhttp://repositorio.unesp.br/oai/requestopendoar:29462024-08-05T16:50:29.766094Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)false |
dc.title.none.fl_str_mv |
Miniaturized turbidimetric assay: A green option for the analysis of besifloxacin in ophthalmic suspension |
title |
Miniaturized turbidimetric assay: A green option for the analysis of besifloxacin in ophthalmic suspension |
spellingShingle |
Miniaturized turbidimetric assay: A green option for the analysis of besifloxacin in ophthalmic suspension Tótoli, Eliane Gandolpho [UNESP] Besifloxacin Green chemistry Miniaturized turbidimetric assay Quality control Validation |
title_short |
Miniaturized turbidimetric assay: A green option for the analysis of besifloxacin in ophthalmic suspension |
title_full |
Miniaturized turbidimetric assay: A green option for the analysis of besifloxacin in ophthalmic suspension |
title_fullStr |
Miniaturized turbidimetric assay: A green option for the analysis of besifloxacin in ophthalmic suspension |
title_full_unstemmed |
Miniaturized turbidimetric assay: A green option for the analysis of besifloxacin in ophthalmic suspension |
title_sort |
Miniaturized turbidimetric assay: A green option for the analysis of besifloxacin in ophthalmic suspension |
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 |
Besifloxacin Green chemistry Miniaturized turbidimetric assay Quality control Validation |
topic |
Besifloxacin Green chemistry Miniaturized turbidimetric assay Quality control Validation |
description |
Besifloxacin is an important antimicrobial agent, belonging to the class of fluoroquinolones, used in the treatment of infectious conjunctivitis. Quality control of this active pharmaceutical ingredient is essential, since poor quality antimicrobials may contribute to the aggravation of the worrying picture of bacterial resistance. Thus, analytical methods need to be developed, validated and improved for that purpose. It is also important that these methods be environmentally friendly, as ensuring the quality of products without harming the environment meets the global needs. The aim of the study was the development and validation of a miniaturized turbidimetric microbiological method for the analysis of besifloxacin hydrochloride (BSF) in ophthalmic suspension. The analyzes were performed in 96-well microplates using Staphylococcus epidermidis ATCC 12228 as test microorganism and BHI broth. The method was validated according to ICH guidelines and showed to be linear (in a range of 0.5–8.0 μg mL−1), precise, accurate, robust and selective. Study of photo-degradation kinetics of BSF sample showed a zero order reaction. A comparative study with a previously validated HPLC method showed that the methods are interchangeable. This work shows the great potential of the proposed method of being introduced in routine analyzes of quality control of BSF in ophthalmic suspension as an option in line with the principles of Green Chemistry. |
publishDate |
2020 |
dc.date.none.fl_str_mv |
2020-12-12T02:30:13Z 2020-12-12T02:30:13Z 2020-03-01 |
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/10.1016/j.talanta.2019.120532 Talanta, v. 209. 0039-9140 http://hdl.handle.net/11449/201348 10.1016/j.talanta.2019.120532 2-s2.0-85075493489 |
url |
http://dx.doi.org/10.1016/j.talanta.2019.120532 http://hdl.handle.net/11449/201348 |
identifier_str_mv |
Talanta, v. 209. 0039-9140 10.1016/j.talanta.2019.120532 2-s2.0-85075493489 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
Talanta |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
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 |
|
_version_ |
1808128708831084544 |