Miniaturized turbidimetric assay: A green option for the analysis of besifloxacin in ophthalmic suspension

Detalhes bibliográficos
Autor(a) principal: Tótoli, Eliane Gandolpho [UNESP]
Data de Publicação: 2020
Outros Autores: Salgado, Hérida Regina Nunes [UNESP]
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.
id UNSP_91e96fffe0ae2fe269c5a1fce8480c5b
oai_identifier_str oai:repositorio.unesp.br:11449/201348
network_acronym_str UNSP
network_name_str Repositório Institucional da UNESP
repository_id_str 2946
spelling 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