A new reliable and rapid HPLC method for the simultaneous determination of amoxicillin and sulbactam pivoxil in pharmaceuticals. Application to both assay and dissolution samples

Autores
Razuc, Mariela Fernanda; Cabrera, Fernanda Anabel; Garrido, Mariano Enrique; Ramírez Rigo, María Veronica
Año de publicación
2021
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
A fast, efficient and simple high performance liquid chromatographic method was developed and validated for the simultaneous determination of amoxicillin trihydrate (AMO) and sulbactam pivoxil (SP) in oral pharmaceutical dosage forms and, eventually, for their dissolution tests. The difference in molar absorptivities of these compounds constituted an analytical challenge, especially in formulations where AMO was in a higher proportion than SP. A reverse phase C18 column was used with a mobile phase consisting of acetonitrile and water (80:20 v/v) in isocratic mode. The retention times were found to be 2.26 min and 1.34 min for SP and AMO, respectively. The linearity range was evaluated over the concentration range of 2.5 and 250.0 µg mL-1 (correlation coefficients higher than 0.9998). The method was validated according to the International Conference on Harmonization ICH guidelines regarding selectivity, linearity, accuracy, precision, limit of detection, limit of quantification, system suitability and robustness. The validated method was applied for the quantification of AMO and SP in commercial tablets and oral suspensions (AMO/SP ratio between 1:1 and 7:1), being the first method in the open literature that enables the correct quantification of both active ingredients in formulations with an AMO/SP ratio higher than 1:1. Also, the new method was successfully applied for the dissolution study of AMO/SP formulations, which was reported for the first time in the open literature. According to the obtained results, the proposed method can be applied in the quality control of pharmaceuticals containing a combination of amoxicillin and sulbactam pivoxil.
Fil: Razuc, Mariela Fernanda. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Bahía Blanca. Instituto de Química del Sur. Universidad Nacional del Sur. Departamento de Química. Instituto de Química del Sur; Argentina. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; Argentina
Fil: Cabrera, Fernanda Anabel. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Bahía Blanca. Planta Piloto de Ingeniería Química. Universidad Nacional del Sur. Planta Piloto de Ingeniería Química; Argentina
Fil: Garrido, Mariano Enrique. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Bahía Blanca. Instituto de Química del Sur. Universidad Nacional del Sur. Departamento de Química. Instituto de Química del Sur; Argentina. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; Argentina
Fil: Ramírez Rigo, María Veronica. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Bahía Blanca. Planta Piloto de Ingeniería Química. Universidad Nacional del Sur. Planta Piloto de Ingeniería Química; Argentina. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; Argentina
Materia
AMOXICILLIN TRIHYDRATE
SULBACTAM PIVOXIL
HPLC
METHOD VALIDATION
DISSOLUTION
ORAL PHARMACEUTICAL DOSAGE FORMS
Nivel de accesibilidad
acceso abierto
Condiciones de uso
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
Repositorio
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/167135
Acceder
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oai_identifier_str oai:ri.conicet.gov.ar:11336/167135
network_acronym_str CONICETDig
repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling A new reliable and rapid HPLC method for the simultaneous determination of amoxicillin and sulbactam pivoxil in pharmaceuticals. Application to both assay and dissolution samplesRazuc, Mariela FernandaCabrera, Fernanda AnabelGarrido, Mariano EnriqueRamírez Rigo, María VeronicaAMOXICILLIN TRIHYDRATESULBACTAM PIVOXILHPLCMETHOD VALIDATIONDISSOLUTIONORAL PHARMACEUTICAL DOSAGE FORMShttps://purl.org/becyt/ford/1.4https://purl.org/becyt/ford/1A fast, efficient and simple high performance liquid chromatographic method was developed and validated for the simultaneous determination of amoxicillin trihydrate (AMO) and sulbactam pivoxil (SP) in oral pharmaceutical dosage forms and, eventually, for their dissolution tests. The difference in molar absorptivities of these compounds constituted an analytical challenge, especially in formulations where AMO was in a higher proportion than SP. A reverse phase C18 column was used with a mobile phase consisting of acetonitrile and water (80:20 v/v) in isocratic mode. The retention times were found to be 2.26 min and 1.34 min for SP and AMO, respectively. The linearity range was evaluated over the concentration range of 2.5 and 250.0 µg mL-1 (correlation coefficients higher than 0.9998). The method was validated according to the International Conference on Harmonization ICH guidelines regarding selectivity, linearity, accuracy, precision, limit of detection, limit of quantification, system suitability and robustness. The validated method was applied for the quantification of AMO and SP in commercial tablets and oral suspensions (AMO/SP ratio between 1:1 and 7:1), being the first method in the open literature that enables the correct quantification of both active ingredients in formulations with an AMO/SP ratio higher than 1:1. Also, the new method was successfully applied for the dissolution study of AMO/SP formulations, which was reported for the first time in the open literature. According to the obtained results, the proposed method can be applied in the quality control of pharmaceuticals containing a combination of amoxicillin and sulbactam pivoxil.Fil: Razuc, Mariela Fernanda. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Bahía Blanca. Instituto de Química del Sur. Universidad Nacional del Sur. Departamento de Química. Instituto de Química del Sur; Argentina. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; ArgentinaFil: Cabrera, Fernanda Anabel. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Bahía Blanca. Planta Piloto de Ingeniería Química. Universidad Nacional del Sur. Planta Piloto de Ingeniería Química; ArgentinaFil: Garrido, Mariano Enrique. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Bahía Blanca. Instituto de Química del Sur. Universidad Nacional del Sur. Departamento de Química. Instituto de Química del Sur; Argentina. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; ArgentinaFil: Ramírez Rigo, María Veronica. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Bahía Blanca. Planta Piloto de Ingeniería Química. Universidad Nacional del Sur. Planta Piloto de Ingeniería Química; Argentina. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; ArgentinaMarmara University2021-12-03info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/167135Razuc, Mariela Fernanda; Cabrera, Fernanda Anabel; Garrido, Mariano Enrique; Ramírez Rigo, María Veronica; A new reliable and rapid HPLC method for the simultaneous determination of amoxicillin and sulbactam pivoxil in pharmaceuticals. Application to both assay and dissolution samples; Marmara University; Journal of Research in Pharmacy; 26; 1; 3-12-2021; 1-132630-6344CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/https://jrespharm.com/abstract.php?id=998info:eu-repo/semantics/altIdentifier/doi/10.29228/jrp.109info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-10-22T11:36:57Zoai:ri.conicet.gov.ar:11336/167135instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982025-10-22 11:36:57.991CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv A new reliable and rapid HPLC method for the simultaneous determination of amoxicillin and sulbactam pivoxil in pharmaceuticals. Application to both assay and dissolution samples
title A new reliable and rapid HPLC method for the simultaneous determination of amoxicillin and sulbactam pivoxil in pharmaceuticals. Application to both assay and dissolution samples
spellingShingle A new reliable and rapid HPLC method for the simultaneous determination of amoxicillin and sulbactam pivoxil in pharmaceuticals. Application to both assay and dissolution samples
Razuc, Mariela Fernanda
AMOXICILLIN TRIHYDRATE
SULBACTAM PIVOXIL
HPLC
METHOD VALIDATION
DISSOLUTION
ORAL PHARMACEUTICAL DOSAGE FORMS
title_short A new reliable and rapid HPLC method for the simultaneous determination of amoxicillin and sulbactam pivoxil in pharmaceuticals. Application to both assay and dissolution samples
title_full A new reliable and rapid HPLC method for the simultaneous determination of amoxicillin and sulbactam pivoxil in pharmaceuticals. Application to both assay and dissolution samples
title_fullStr A new reliable and rapid HPLC method for the simultaneous determination of amoxicillin and sulbactam pivoxil in pharmaceuticals. Application to both assay and dissolution samples
title_full_unstemmed A new reliable and rapid HPLC method for the simultaneous determination of amoxicillin and sulbactam pivoxil in pharmaceuticals. Application to both assay and dissolution samples
title_sort A new reliable and rapid HPLC method for the simultaneous determination of amoxicillin and sulbactam pivoxil in pharmaceuticals. Application to both assay and dissolution samples
dc.creator.none.fl_str_mv Razuc, Mariela Fernanda
Cabrera, Fernanda Anabel
Garrido, Mariano Enrique
Ramírez Rigo, María Veronica
author Razuc, Mariela Fernanda
author_facet Razuc, Mariela Fernanda
Cabrera, Fernanda Anabel
Garrido, Mariano Enrique
Ramírez Rigo, María Veronica
author_role author
author2 Cabrera, Fernanda Anabel
Garrido, Mariano Enrique
Ramírez Rigo, María Veronica
author2_role author
author
author
dc.subject.none.fl_str_mv AMOXICILLIN TRIHYDRATE
SULBACTAM PIVOXIL
HPLC
METHOD VALIDATION
DISSOLUTION
ORAL PHARMACEUTICAL DOSAGE FORMS
topic AMOXICILLIN TRIHYDRATE
SULBACTAM PIVOXIL
HPLC
METHOD VALIDATION
DISSOLUTION
ORAL PHARMACEUTICAL DOSAGE FORMS
purl_subject.fl_str_mv https://purl.org/becyt/ford/1.4
https://purl.org/becyt/ford/1
dc.description.none.fl_txt_mv A fast, efficient and simple high performance liquid chromatographic method was developed and validated for the simultaneous determination of amoxicillin trihydrate (AMO) and sulbactam pivoxil (SP) in oral pharmaceutical dosage forms and, eventually, for their dissolution tests. The difference in molar absorptivities of these compounds constituted an analytical challenge, especially in formulations where AMO was in a higher proportion than SP. A reverse phase C18 column was used with a mobile phase consisting of acetonitrile and water (80:20 v/v) in isocratic mode. The retention times were found to be 2.26 min and 1.34 min for SP and AMO, respectively. The linearity range was evaluated over the concentration range of 2.5 and 250.0 µg mL-1 (correlation coefficients higher than 0.9998). The method was validated according to the International Conference on Harmonization ICH guidelines regarding selectivity, linearity, accuracy, precision, limit of detection, limit of quantification, system suitability and robustness. The validated method was applied for the quantification of AMO and SP in commercial tablets and oral suspensions (AMO/SP ratio between 1:1 and 7:1), being the first method in the open literature that enables the correct quantification of both active ingredients in formulations with an AMO/SP ratio higher than 1:1. Also, the new method was successfully applied for the dissolution study of AMO/SP formulations, which was reported for the first time in the open literature. According to the obtained results, the proposed method can be applied in the quality control of pharmaceuticals containing a combination of amoxicillin and sulbactam pivoxil.
Fil: Razuc, Mariela Fernanda. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Bahía Blanca. Instituto de Química del Sur. Universidad Nacional del Sur. Departamento de Química. Instituto de Química del Sur; Argentina. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; Argentina
Fil: Cabrera, Fernanda Anabel. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Bahía Blanca. Planta Piloto de Ingeniería Química. Universidad Nacional del Sur. Planta Piloto de Ingeniería Química; Argentina
Fil: Garrido, Mariano Enrique. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Bahía Blanca. Instituto de Química del Sur. Universidad Nacional del Sur. Departamento de Química. Instituto de Química del Sur; Argentina. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; Argentina
Fil: Ramírez Rigo, María Veronica. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Bahía Blanca. Planta Piloto de Ingeniería Química. Universidad Nacional del Sur. Planta Piloto de Ingeniería Química; Argentina. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; Argentina
description A fast, efficient and simple high performance liquid chromatographic method was developed and validated for the simultaneous determination of amoxicillin trihydrate (AMO) and sulbactam pivoxil (SP) in oral pharmaceutical dosage forms and, eventually, for their dissolution tests. The difference in molar absorptivities of these compounds constituted an analytical challenge, especially in formulations where AMO was in a higher proportion than SP. A reverse phase C18 column was used with a mobile phase consisting of acetonitrile and water (80:20 v/v) in isocratic mode. The retention times were found to be 2.26 min and 1.34 min for SP and AMO, respectively. The linearity range was evaluated over the concentration range of 2.5 and 250.0 µg mL-1 (correlation coefficients higher than 0.9998). The method was validated according to the International Conference on Harmonization ICH guidelines regarding selectivity, linearity, accuracy, precision, limit of detection, limit of quantification, system suitability and robustness. The validated method was applied for the quantification of AMO and SP in commercial tablets and oral suspensions (AMO/SP ratio between 1:1 and 7:1), being the first method in the open literature that enables the correct quantification of both active ingredients in formulations with an AMO/SP ratio higher than 1:1. Also, the new method was successfully applied for the dissolution study of AMO/SP formulations, which was reported for the first time in the open literature. According to the obtained results, the proposed method can be applied in the quality control of pharmaceuticals containing a combination of amoxicillin and sulbactam pivoxil.
publishDate 2021
dc.date.none.fl_str_mv 2021-12-03
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
http://purl.org/coar/resource_type/c_6501
info:ar-repo/semantics/articulo
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/11336/167135
Razuc, Mariela Fernanda; Cabrera, Fernanda Anabel; Garrido, Mariano Enrique; Ramírez Rigo, María Veronica; A new reliable and rapid HPLC method for the simultaneous determination of amoxicillin and sulbactam pivoxil in pharmaceuticals. Application to both assay and dissolution samples; Marmara University; Journal of Research in Pharmacy; 26; 1; 3-12-2021; 1-13
2630-6344
CONICET Digital
CONICET
url http://hdl.handle.net/11336/167135
identifier_str_mv Razuc, Mariela Fernanda; Cabrera, Fernanda Anabel; Garrido, Mariano Enrique; Ramírez Rigo, María Veronica; A new reliable and rapid HPLC method for the simultaneous determination of amoxicillin and sulbactam pivoxil in pharmaceuticals. Application to both assay and dissolution samples; Marmara University; Journal of Research in Pharmacy; 26; 1; 3-12-2021; 1-13
2630-6344
CONICET Digital
CONICET
dc.language.none.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/url/https://jrespharm.com/abstract.php?id=998
info:eu-repo/semantics/altIdentifier/doi/10.29228/jrp.109
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
eu_rights_str_mv openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Marmara University
publisher.none.fl_str_mv Marmara University
dc.source.none.fl_str_mv reponame:CONICET Digital (CONICET)
instname:Consejo Nacional de Investigaciones Científicas y Técnicas
reponame_str CONICET Digital (CONICET)
collection CONICET Digital (CONICET)
instname_str Consejo Nacional de Investigaciones Científicas y Técnicas
repository.name.fl_str_mv CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicas
repository.mail.fl_str_mv dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar
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score 12.982451

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