Development and validation of a stability-indicating MEKC method for determination of flucloxacillin sodium in capsules
Autor(a) principal: | |
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Data de Publicação: | 2014 |
Outros Autores: | , , |
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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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 |
|
_version_ |
1808129436253421568 |