Validation of Ninhydrin Quantitative Method for Cephalexin Generic Tablets

Autores
Delfino, Mario Raul; Monzón, Celina María; Sarno, María del Carmen Teresa
Año de publicación
2013
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
The Medicinal Plant of Corrientes, Argentina, elaborates, distributes and provides free 500 mg cephalexin tablets in hospitals and health care centers. HPLC-UV is the reference method to quantify this antibiotic. The spectrophotometric ninhydrin method was applied for cephalexin quantification and analytical parameters for its validation were determined. The linearity of this method was in the range 0.04-0.20 mg/mL, responding to y = 2.2338x + 0.0007, with R2 = 0.9995. The RSD% found was 0.41, indicating a good repeatability of the analytical procedure. Exactitude in recovery experience was 98.50-101.33%. Comparison using t-tests and F-test indicates that there are no significant differences between results using both methods, with a confidence level of 95%. Specificity and intermediate precision assays were satisfactory. These parameters complete the validation of ninhydrin method, according to requirements of both United States and Argentinean Pharmacopoeia, for its application on cephalexin quality control in generic tablets.
Fil: Delfino, Mario Raul. Universidad Nacional del Nordeste. Facultad de Ciencias Exactas Naturales y Agrimensura. Departamento de Química; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: Monzón, Celina María. Universidad Nacional del Nordeste. Facultad de Ciencias Exactas Naturales y Agrimensura. Departamento de Química; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Nordeste; Argentina
Fil: Sarno, María del Carmen Teresa. Universidad Nacional del Nordeste. Facultad de Ciencias Exactas Naturales y Agrimensura. Departamento de Química; Argentina
Materia
Antibiotic
B-Lactamic
Cephalexin
Spectrophotometry
Validation
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:11336/8558
Acceder
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oai_identifier_str oai:ri.conicet.gov.ar:11336/8558
network_acronym_str CONICETDig
repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling Validation of Ninhydrin Quantitative Method for Cephalexin Generic TabletsDelfino, Mario RaulMonzón, Celina MaríaSarno, María del Carmen TeresaAntibioticB-LactamicCephalexinSpectrophotometryValidationhttps://purl.org/becyt/ford/1.4https://purl.org/becyt/ford/1The Medicinal Plant of Corrientes, Argentina, elaborates, distributes and provides free 500 mg cephalexin tablets in hospitals and health care centers. HPLC-UV is the reference method to quantify this antibiotic. The spectrophotometric ninhydrin method was applied for cephalexin quantification and analytical parameters for its validation were determined. The linearity of this method was in the range 0.04-0.20 mg/mL, responding to y = 2.2338x + 0.0007, with R2 = 0.9995. The RSD% found was 0.41, indicating a good repeatability of the analytical procedure. Exactitude in recovery experience was 98.50-101.33%. Comparison using t-tests and F-test indicates that there are no significant differences between results using both methods, with a confidence level of 95%. Specificity and intermediate precision assays were satisfactory. These parameters complete the validation of ninhydrin method, according to requirements of both United States and Argentinean Pharmacopoeia, for its application on cephalexin quality control in generic tablets.Fil: Delfino, Mario Raul. Universidad Nacional del Nordeste. Facultad de Ciencias Exactas Naturales y Agrimensura. Departamento de Química; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Monzón, Celina María. Universidad Nacional del Nordeste. Facultad de Ciencias Exactas Naturales y Agrimensura. Departamento de Química; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Nordeste; ArgentinaFil: Sarno, María del Carmen Teresa. Universidad Nacional del Nordeste. Facultad de Ciencias Exactas Naturales y Agrimensura. Departamento de Química; ArgentinaBentham Science Publishers2013-02info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/8558Delfino, Mario Raul; Monzón, Celina María; Sarno, María del Carmen Teresa; Validation of Ninhydrin Quantitative Method for Cephalexin Generic Tablets; Bentham Science Publishers; Current Pharmaceutical Analysis; 9; 2-2013; 13-191573-41291875-676Xenginfo:eu-repo/semantics/altIdentifier/url/http://www.eurekaselect.com/105994/articleinfo:eu-repo/semantics/altIdentifier/doi/10.2174/1573412911309010004info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-29T09:46:12Zoai:ri.conicet.gov.ar:11336/8558instacron: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:34982025-09-29 09:46:13.159CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Validation of Ninhydrin Quantitative Method for Cephalexin Generic Tablets
title Validation of Ninhydrin Quantitative Method for Cephalexin Generic Tablets
spellingShingle Validation of Ninhydrin Quantitative Method for Cephalexin Generic Tablets
Delfino, Mario Raul
Antibiotic
B-Lactamic
Cephalexin
Spectrophotometry
Validation
title_short Validation of Ninhydrin Quantitative Method for Cephalexin Generic Tablets
title_full Validation of Ninhydrin Quantitative Method for Cephalexin Generic Tablets
title_fullStr Validation of Ninhydrin Quantitative Method for Cephalexin Generic Tablets
title_full_unstemmed Validation of Ninhydrin Quantitative Method for Cephalexin Generic Tablets
title_sort Validation of Ninhydrin Quantitative Method for Cephalexin Generic Tablets
dc.creator.none.fl_str_mv Delfino, Mario Raul
Monzón, Celina María
Sarno, María del Carmen Teresa
author Delfino, Mario Raul
author_facet Delfino, Mario Raul
Monzón, Celina María
Sarno, María del Carmen Teresa
author_role author
author2 Monzón, Celina María
Sarno, María del Carmen Teresa
author2_role author
author
dc.subject.none.fl_str_mv Antibiotic
B-Lactamic
Cephalexin
Spectrophotometry
Validation
topic Antibiotic
B-Lactamic
Cephalexin
Spectrophotometry
Validation
purl_subject.fl_str_mv https://purl.org/becyt/ford/1.4
https://purl.org/becyt/ford/1
dc.description.none.fl_txt_mv The Medicinal Plant of Corrientes, Argentina, elaborates, distributes and provides free 500 mg cephalexin tablets in hospitals and health care centers. HPLC-UV is the reference method to quantify this antibiotic. The spectrophotometric ninhydrin method was applied for cephalexin quantification and analytical parameters for its validation were determined. The linearity of this method was in the range 0.04-0.20 mg/mL, responding to y = 2.2338x + 0.0007, with R2 = 0.9995. The RSD% found was 0.41, indicating a good repeatability of the analytical procedure. Exactitude in recovery experience was 98.50-101.33%. Comparison using t-tests and F-test indicates that there are no significant differences between results using both methods, with a confidence level of 95%. Specificity and intermediate precision assays were satisfactory. These parameters complete the validation of ninhydrin method, according to requirements of both United States and Argentinean Pharmacopoeia, for its application on cephalexin quality control in generic tablets.
Fil: Delfino, Mario Raul. Universidad Nacional del Nordeste. Facultad de Ciencias Exactas Naturales y Agrimensura. Departamento de Química; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: Monzón, Celina María. Universidad Nacional del Nordeste. Facultad de Ciencias Exactas Naturales y Agrimensura. Departamento de Química; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Nordeste; Argentina
Fil: Sarno, María del Carmen Teresa. Universidad Nacional del Nordeste. Facultad de Ciencias Exactas Naturales y Agrimensura. Departamento de Química; Argentina
description The Medicinal Plant of Corrientes, Argentina, elaborates, distributes and provides free 500 mg cephalexin tablets in hospitals and health care centers. HPLC-UV is the reference method to quantify this antibiotic. The spectrophotometric ninhydrin method was applied for cephalexin quantification and analytical parameters for its validation were determined. The linearity of this method was in the range 0.04-0.20 mg/mL, responding to y = 2.2338x + 0.0007, with R2 = 0.9995. The RSD% found was 0.41, indicating a good repeatability of the analytical procedure. Exactitude in recovery experience was 98.50-101.33%. Comparison using t-tests and F-test indicates that there are no significant differences between results using both methods, with a confidence level of 95%. Specificity and intermediate precision assays were satisfactory. These parameters complete the validation of ninhydrin method, according to requirements of both United States and Argentinean Pharmacopoeia, for its application on cephalexin quality control in generic tablets.
publishDate 2013
dc.date.none.fl_str_mv 2013-02
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/11336/8558
Delfino, Mario Raul; Monzón, Celina María; Sarno, María del Carmen Teresa; Validation of Ninhydrin Quantitative Method for Cephalexin Generic Tablets; Bentham Science Publishers; Current Pharmaceutical Analysis; 9; 2-2013; 13-19
1573-4129
1875-676X
url http://hdl.handle.net/11336/8558
identifier_str_mv Delfino, Mario Raul; Monzón, Celina María; Sarno, María del Carmen Teresa; Validation of Ninhydrin Quantitative Method for Cephalexin Generic Tablets; Bentham Science Publishers; Current Pharmaceutical Analysis; 9; 2-2013; 13-19
1573-4129
1875-676X
dc.language.none.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/url/http://www.eurekaselect.com/105994/article
info:eu-repo/semantics/altIdentifier/doi/10.2174/1573412911309010004
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
application/pdf
dc.publisher.none.fl_str_mv Bentham Science Publishers
publisher.none.fl_str_mv Bentham Science Publishers
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 13.070432

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