Zoledronate and related impurities analysis by capillary zone electrophoresis

Autores
Alvarez, Gisela Solange; Foglia, María Lucía; Camporotondi, Daniela Edhit; Giorgieri, Sergio; Desimone, Martín Federico; Diaz, Luis Eduardo
Año de publicación
2014
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
A capillary zone electrophoretic (CZE) method has been developed for the determination of zoledronate and its related impurities (phosphyte and phosphate). Successful separation of the drug from the impurities was achieved using 7.5 mM of phthalic acid adjusted to pH 3.50 with TRIS, as background electrolyte with an indirect detection at 205 nm. The optimized method was validated for specificity, precision, linearity and accuracy. The limit of detection was 1.8 µg ml-1 and the limit of quantification was 5.9 µg ml-1 for phosphyte. The limit of detection was 2.8 µg ml-1 and the limit of quantification was 9.3 µg ml-1 for phosphate. The developed CZE method used to determine zoledronate, phosphyte and phosphate as bisphosphonates impurities can be used to evaluate the quality of regular production samples of zoledronate.
Fil: Alvarez, Gisela Solange. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay. Instituto de Química y Metabolismo del Fármaco. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Instituto de Química y Metabolismo del Fármaco; Argentina
Fil: Foglia, María Lucía. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay. Instituto de Química y Metabolismo del Fármaco. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Instituto de Química y Metabolismo del Fármaco; Argentina
Fil: Camporotondi, Daniela Edhit. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica; Argentina
Fil: Giorgieri, Sergio. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: Desimone, Martín Federico. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay. Instituto de Química y Metabolismo del Fármaco. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Instituto de Química y Metabolismo del Fármaco; Argentina
Fil: Diaz, Luis Eduardo. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay. Instituto de Química y Metabolismo del Fármaco. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Instituto de Química y Metabolismo del Fármaco; Argentina
Materia
Capillary Zone Electrophoresis
Zoledronate
Biphosphonates
Impurities
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:11336/30729

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network_name_str CONICET Digital (CONICET)
spelling Zoledronate and related impurities analysis by capillary zone electrophoresisAlvarez, Gisela SolangeFoglia, María LucíaCamporotondi, Daniela EdhitGiorgieri, SergioDesimone, Martín FedericoDiaz, Luis EduardoCapillary Zone ElectrophoresisZoledronateBiphosphonatesImpuritieshttps://purl.org/becyt/ford/1.4https://purl.org/becyt/ford/1A capillary zone electrophoretic (CZE) method has been developed for the determination of zoledronate and its related impurities (phosphyte and phosphate). Successful separation of the drug from the impurities was achieved using 7.5 mM of phthalic acid adjusted to pH 3.50 with TRIS, as background electrolyte with an indirect detection at 205 nm. The optimized method was validated for specificity, precision, linearity and accuracy. The limit of detection was 1.8 µg ml-1 and the limit of quantification was 5.9 µg ml-1 for phosphyte. The limit of detection was 2.8 µg ml-1 and the limit of quantification was 9.3 µg ml-1 for phosphate. The developed CZE method used to determine zoledronate, phosphyte and phosphate as bisphosphonates impurities can be used to evaluate the quality of regular production samples of zoledronate.Fil: Alvarez, Gisela Solange. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay. Instituto de Química y Metabolismo del Fármaco. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Instituto de Química y Metabolismo del Fármaco; ArgentinaFil: Foglia, María Lucía. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay. Instituto de Química y Metabolismo del Fármaco. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Instituto de Química y Metabolismo del Fármaco; ArgentinaFil: Camporotondi, Daniela Edhit. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica; ArgentinaFil: Giorgieri, Sergio. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Desimone, Martín Federico. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay. Instituto de Química y Metabolismo del Fármaco. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Instituto de Química y Metabolismo del Fármaco; ArgentinaFil: Diaz, Luis Eduardo. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay. Instituto de Química y Metabolismo del Fármaco. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Instituto de Química y Metabolismo del Fármaco; ArgentinaBentham Science Publishers2014-06info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfapplication/pdfapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/30729Diaz, Luis Eduardo; Desimone, Martín Federico; Giorgieri, Sergio; Camporotondi, Daniela Edhit; Foglia, María Lucía; Alvarez, Gisela Solange; et al.; Zoledronate and related impurities analysis by capillary zone electrophoresis; Bentham Science Publishers; Current Analytical Chemistry; 10; 2; 6-2014; 231-2341573-4110CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/http://www.eurekaselect.com/110254info:eu-repo/semantics/altIdentifier/doi/10.2174/15734110113099990009info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-03T09:46:21Zoai:ri.conicet.gov.ar:11336/30729instacron: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:34982025-09-03 09:46:21.608CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Zoledronate and related impurities analysis by capillary zone electrophoresis
title Zoledronate and related impurities analysis by capillary zone electrophoresis
spellingShingle Zoledronate and related impurities analysis by capillary zone electrophoresis
Alvarez, Gisela Solange
Capillary Zone Electrophoresis
Zoledronate
Biphosphonates
Impurities
title_short Zoledronate and related impurities analysis by capillary zone electrophoresis
title_full Zoledronate and related impurities analysis by capillary zone electrophoresis
title_fullStr Zoledronate and related impurities analysis by capillary zone electrophoresis
title_full_unstemmed Zoledronate and related impurities analysis by capillary zone electrophoresis
title_sort Zoledronate and related impurities analysis by capillary zone electrophoresis
dc.creator.none.fl_str_mv Alvarez, Gisela Solange
Foglia, María Lucía
Camporotondi, Daniela Edhit
Giorgieri, Sergio
Desimone, Martín Federico
Diaz, Luis Eduardo
author Alvarez, Gisela Solange
author_facet Alvarez, Gisela Solange
Foglia, María Lucía
Camporotondi, Daniela Edhit
Giorgieri, Sergio
Desimone, Martín Federico
Diaz, Luis Eduardo
author_role author
author2 Foglia, María Lucía
Camporotondi, Daniela Edhit
Giorgieri, Sergio
Desimone, Martín Federico
Diaz, Luis Eduardo
author2_role author
author
author
author
author
dc.subject.none.fl_str_mv Capillary Zone Electrophoresis
Zoledronate
Biphosphonates
Impurities
topic Capillary Zone Electrophoresis
Zoledronate
Biphosphonates
Impurities
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 capillary zone electrophoretic (CZE) method has been developed for the determination of zoledronate and its related impurities (phosphyte and phosphate). Successful separation of the drug from the impurities was achieved using 7.5 mM of phthalic acid adjusted to pH 3.50 with TRIS, as background electrolyte with an indirect detection at 205 nm. The optimized method was validated for specificity, precision, linearity and accuracy. The limit of detection was 1.8 µg ml-1 and the limit of quantification was 5.9 µg ml-1 for phosphyte. The limit of detection was 2.8 µg ml-1 and the limit of quantification was 9.3 µg ml-1 for phosphate. The developed CZE method used to determine zoledronate, phosphyte and phosphate as bisphosphonates impurities can be used to evaluate the quality of regular production samples of zoledronate.
Fil: Alvarez, Gisela Solange. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay. Instituto de Química y Metabolismo del Fármaco. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Instituto de Química y Metabolismo del Fármaco; Argentina
Fil: Foglia, María Lucía. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay. Instituto de Química y Metabolismo del Fármaco. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Instituto de Química y Metabolismo del Fármaco; Argentina
Fil: Camporotondi, Daniela Edhit. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica; Argentina
Fil: Giorgieri, Sergio. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: Desimone, Martín Federico. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay. Instituto de Química y Metabolismo del Fármaco. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Instituto de Química y Metabolismo del Fármaco; Argentina
Fil: Diaz, Luis Eduardo. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay. Instituto de Química y Metabolismo del Fármaco. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Instituto de Química y Metabolismo del Fármaco; Argentina
description A capillary zone electrophoretic (CZE) method has been developed for the determination of zoledronate and its related impurities (phosphyte and phosphate). Successful separation of the drug from the impurities was achieved using 7.5 mM of phthalic acid adjusted to pH 3.50 with TRIS, as background electrolyte with an indirect detection at 205 nm. The optimized method was validated for specificity, precision, linearity and accuracy. The limit of detection was 1.8 µg ml-1 and the limit of quantification was 5.9 µg ml-1 for phosphyte. The limit of detection was 2.8 µg ml-1 and the limit of quantification was 9.3 µg ml-1 for phosphate. The developed CZE method used to determine zoledronate, phosphyte and phosphate as bisphosphonates impurities can be used to evaluate the quality of regular production samples of zoledronate.
publishDate 2014
dc.date.none.fl_str_mv 2014-06
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/11336/30729
Diaz, Luis Eduardo; Desimone, Martín Federico; Giorgieri, Sergio; Camporotondi, Daniela Edhit; Foglia, María Lucía; Alvarez, Gisela Solange; et al.; Zoledronate and related impurities analysis by capillary zone electrophoresis; Bentham Science Publishers; Current Analytical Chemistry; 10; 2; 6-2014; 231-234
1573-4110
CONICET Digital
CONICET
url http://hdl.handle.net/11336/30729
identifier_str_mv Diaz, Luis Eduardo; Desimone, Martín Federico; Giorgieri, Sergio; Camporotondi, Daniela Edhit; Foglia, María Lucía; Alvarez, Gisela Solange; et al.; Zoledronate and related impurities analysis by capillary zone electrophoresis; Bentham Science Publishers; Current Analytical Chemistry; 10; 2; 6-2014; 231-234
1573-4110
CONICET Digital
CONICET
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/110254
info:eu-repo/semantics/altIdentifier/doi/10.2174/15734110113099990009
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
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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