Development and validation of a stability-indicating MEKC method for determination of flucloxacillin sodium in capsules

Detalhes bibliográficos
Autor(a) principal: Fiorentino, Flávia Angélica Másquio [UNESP]
Data de Publicação: 2014
Outros Autores: Sangoi, Maximiliano da Silva, Steppe, Martin, Salgado, Hérida Regina Nunes [UNESP]
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da UNESP
Texto Completo: http://dx.doi.org/10.2174/15734110113099990016
http://hdl.handle.net/11449/232172
Resumo: Flucloxacillin (FLU) is a semi-synthetic penicillin active against Gram-positive bacteria such as streptococci and penicilinase-producing staphylococci, including methicillin-susceptible S. aureus. A simple, rapid and reproducible stability-indicating micellar electrokinetic chromatography (MEKC) method was developed and validated for analysis of flucloxacillin sodium in capsules, using nimesulide as internal standard. The MEKC method was performed on a fusedsilica capillary (50 μm id; effective length of 40 cm). The background electrolyte consists of 50 mM borate and 80 mM anionic surfactant SDS quantities at pH 8.5. The separation was achieved at 20 kV applied voltage and 27.5 °C. The injection was performed using the hydrodinamic mode at 50 mbar for 4s, with detection at 210 nm. The method was linear in the range of 20-100 μg mL-1 (r = 0.9996) with adequate results for the precision (≤ 1.60%) and accuracy (99.45%). The specificity and stability-indicating capability were demonstrated through forced degradation studies and with placebo solution, which showed that there is no interference of the excipients. LOD and LOQ were 3.20 and 9.70 μg mL-1, respectively. The method proved to be robust by a fractional factorial design evaluation. The method was successfully applied for the drug analysis and the results were compared to liquid chromatographic method, showing non-significant difference (p > 0.005). The proposed method might be applied in routine quality control in the pharmaceutical industries. © 2014 Bentham Science Publishers.
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spelling Development and validation of a stability-indicating MEKC method for determination of flucloxacillin sodium in capsulesCapsulesFlucloxacillin sodiumMEKC methodPenicillinQuality controlValidationFlucloxacillin (FLU) is a semi-synthetic penicillin active against Gram-positive bacteria such as streptococci and penicilinase-producing staphylococci, including methicillin-susceptible S. aureus. A simple, rapid and reproducible stability-indicating micellar electrokinetic chromatography (MEKC) method was developed and validated for analysis of flucloxacillin sodium in capsules, using nimesulide as internal standard. The MEKC method was performed on a fusedsilica capillary (50 μm id; effective length of 40 cm). The background electrolyte consists of 50 mM borate and 80 mM anionic surfactant SDS quantities at pH 8.5. The separation was achieved at 20 kV applied voltage and 27.5 °C. The injection was performed using the hydrodinamic mode at 50 mbar for 4s, with detection at 210 nm. The method was linear in the range of 20-100 μg mL-1 (r = 0.9996) with adequate results for the precision (≤ 1.60%) and accuracy (99.45%). The specificity and stability-indicating capability were demonstrated through forced degradation studies and with placebo solution, which showed that there is no interference of the excipients. LOD and LOQ were 3.20 and 9.70 μg mL-1, respectively. The method proved to be robust by a fractional factorial design evaluation. The method was successfully applied for the drug analysis and the results were compared to liquid chromatographic method, showing non-significant difference (p > 0.005). The proposed method might be applied in routine quality control in the pharmaceutical industries. © 2014 Bentham Science Publishers.Univ Estadual Paulista, Araraquara, SPUniversidade Federal do Rio Grande do Sul, Porto Alegre, RSUniv Estadual Paulista, Araraquara, SPUniversidade Estadual Paulista (UNESP)Universidade Federal do Rio Grande do SulFiorentino, Flávia Angélica Másquio [UNESP]Sangoi, Maximiliano da SilvaSteppe, MartinSalgado, Hérida Regina Nunes [UNESP]2022-04-29T09:12:13Z2022-04-29T09:12:13Z2014-01-01info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/article149-157http://dx.doi.org/10.2174/15734110113099990016Current Analytical Chemistry, v. 10, n. 1, p. 149-157, 2014.1573-4110http://hdl.handle.net/11449/23217210.2174/157341101130999900162-s2.0-84889026548Scopusreponame:Repositório Institucional da UNESPinstname:Universidade Estadual Paulista (UNESP)instacron:UNESPengCurrent Analytical Chemistryinfo:eu-repo/semantics/openAccess2024-06-24T13:46:24Zoai:repositorio.unesp.br:11449/232172Repositório InstitucionalPUBhttp://repositorio.unesp.br/oai/requestopendoar:29462024-08-05T22:33:00.894228Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)false
dc.title.none.fl_str_mv Development and validation of a stability-indicating MEKC method for determination of flucloxacillin sodium in capsules
title Development and validation of a stability-indicating MEKC method for determination of flucloxacillin sodium in capsules
spellingShingle Development and validation of a stability-indicating MEKC method for determination of flucloxacillin sodium in capsules
Fiorentino, Flávia Angélica Másquio [UNESP]
Capsules
Flucloxacillin sodium
MEKC method
Penicillin
Quality control
Validation
title_short Development and validation of a stability-indicating MEKC method for determination of flucloxacillin sodium in capsules
title_full Development and validation of a stability-indicating MEKC method for determination of flucloxacillin sodium in capsules
title_fullStr Development and validation of a stability-indicating MEKC method for determination of flucloxacillin sodium in capsules
title_full_unstemmed Development and validation of a stability-indicating MEKC method for determination of flucloxacillin sodium in capsules
title_sort Development and validation of a stability-indicating MEKC method for determination of flucloxacillin sodium in capsules
author Fiorentino, Flávia Angélica Másquio [UNESP]
author_facet Fiorentino, Flávia Angélica Másquio [UNESP]
Sangoi, Maximiliano da Silva
Steppe, Martin
Salgado, Hérida Regina Nunes [UNESP]
author_role author
author2 Sangoi, Maximiliano da Silva
Steppe, Martin
Salgado, Hérida Regina Nunes [UNESP]
author2_role author
author
author
dc.contributor.none.fl_str_mv Universidade Estadual Paulista (UNESP)
Universidade Federal do Rio Grande do Sul
dc.contributor.author.fl_str_mv Fiorentino, Flávia Angélica Másquio [UNESP]
Sangoi, Maximiliano da Silva
Steppe, Martin
Salgado, Hérida Regina Nunes [UNESP]
dc.subject.por.fl_str_mv Capsules
Flucloxacillin sodium
MEKC method
Penicillin
Quality control
Validation
topic Capsules
Flucloxacillin sodium
MEKC method
Penicillin
Quality control
Validation
description Flucloxacillin (FLU) is a semi-synthetic penicillin active against Gram-positive bacteria such as streptococci and penicilinase-producing staphylococci, including methicillin-susceptible S. aureus. A simple, rapid and reproducible stability-indicating micellar electrokinetic chromatography (MEKC) method was developed and validated for analysis of flucloxacillin sodium in capsules, using nimesulide as internal standard. The MEKC method was performed on a fusedsilica capillary (50 μm id; effective length of 40 cm). The background electrolyte consists of 50 mM borate and 80 mM anionic surfactant SDS quantities at pH 8.5. The separation was achieved at 20 kV applied voltage and 27.5 °C. The injection was performed using the hydrodinamic mode at 50 mbar for 4s, with detection at 210 nm. The method was linear in the range of 20-100 μg mL-1 (r = 0.9996) with adequate results for the precision (≤ 1.60%) and accuracy (99.45%). The specificity and stability-indicating capability were demonstrated through forced degradation studies and with placebo solution, which showed that there is no interference of the excipients. LOD and LOQ were 3.20 and 9.70 μg mL-1, respectively. The method proved to be robust by a fractional factorial design evaluation. The method was successfully applied for the drug analysis and the results were compared to liquid chromatographic method, showing non-significant difference (p > 0.005). The proposed method might be applied in routine quality control in the pharmaceutical industries. © 2014 Bentham Science Publishers.
publishDate 2014
dc.date.none.fl_str_mv 2014-01-01
2022-04-29T09:12:13Z
2022-04-29T09:12:13Z
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/10.2174/15734110113099990016
Current Analytical Chemistry, v. 10, n. 1, p. 149-157, 2014.
1573-4110
http://hdl.handle.net/11449/232172
10.2174/15734110113099990016
2-s2.0-84889026548
url http://dx.doi.org/10.2174/15734110113099990016
http://hdl.handle.net/11449/232172
identifier_str_mv Current Analytical Chemistry, v. 10, n. 1, p. 149-157, 2014.
1573-4110
10.2174/15734110113099990016
2-s2.0-84889026548
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv Current Analytical Chemistry
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv 149-157
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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