Validation of Liquid Chromatographic Method for Analysis of Tacrolimus in a Pharmaceutical Dosage Form

Autores
Moyano, Maria Alejandra; Simionato, Laura Daniela; Pizzorno, Maria Teresa; Segall, Adriana Ines
Año de publicación
2006
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
An accurate, simple and reproducible liquid chromatographic method was developed and validated for the determination of  tacrolimus in capsules. The analysis were performed at room temperature on a reverse phase C18 column with UV detection at 210 nm. The mobile phase consisted of  methanol-water (90 + 10) at a constant flow rate of 0.8 mL/min. The method was validated in terms of linearity, precision, accuracy and specificity by forced decomposition of tacrolimus using acid, base, water, hydrogen peroxide, heat and light. The response was linear in the range of 0.09-0.24  mg/mL (r2 = 0.9997). The relative standard deviation values for intra- and interday precision studies were 1.28 and 2.91.  Recoveries ranged between 98.06 and 102.52 %.
Fil: Moyano, Maria Alejandra. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica; Argentina
Fil: Simionato, Laura Daniela. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica; Argentina
Fil: Pizzorno, Maria Teresa. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay; Argentina
Fil: Segall, Adriana Ines. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica; Argentina
Materia
Tacrolimus
HPLC
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:11336/111469
Acceder
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network_acronym_str CONICETDig
repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling Validation of Liquid Chromatographic Method for Analysis of Tacrolimus in a Pharmaceutical Dosage FormMoyano, Maria AlejandraSimionato, Laura DanielaPizzorno, Maria TeresaSegall, Adriana InesTacrolimusHPLCValidationhttps://purl.org/becyt/ford/3.1https://purl.org/becyt/ford/3An accurate, simple and reproducible liquid chromatographic method was developed and validated for the determination of  tacrolimus in capsules. The analysis were performed at room temperature on a reverse phase C18 column with UV detection at 210 nm. The mobile phase consisted of  methanol-water (90 + 10) at a constant flow rate of 0.8 mL/min. The method was validated in terms of linearity, precision, accuracy and specificity by forced decomposition of tacrolimus using acid, base, water, hydrogen peroxide, heat and light. The response was linear in the range of 0.09-0.24  mg/mL (r2 = 0.9997). The relative standard deviation values for intra- and interday precision studies were 1.28 and 2.91.  Recoveries ranged between 98.06 and 102.52 %.Fil: Moyano, Maria Alejandra. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica; ArgentinaFil: Simionato, Laura Daniela. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica; ArgentinaFil: Pizzorno, Maria Teresa. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay; ArgentinaFil: Segall, Adriana Ines. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica; ArgentinaAOAC International2006-12info: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/11336/111469Moyano, Maria Alejandra; Simionato, Laura Daniela; Pizzorno, Maria Teresa; Segall, Adriana Ines; Validation of Liquid Chromatographic Method for Analysis of Tacrolimus in a Pharmaceutical Dosage Form; AOAC International; Journal of AOAC International; 89; 12-2006; 1547-15511060-3271CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/https://pubmed.ncbi.nlm.nih.gov/17225600/info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-03T09:48:51Zoai:ri.conicet.gov.ar:11336/111469instacron: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 09:48:51.449CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Validation of Liquid Chromatographic Method for Analysis of Tacrolimus in a Pharmaceutical Dosage Form
title Validation of Liquid Chromatographic Method for Analysis of Tacrolimus in a Pharmaceutical Dosage Form
spellingShingle Validation of Liquid Chromatographic Method for Analysis of Tacrolimus in a Pharmaceutical Dosage Form
Moyano, Maria Alejandra
Tacrolimus
HPLC
Validation
title_short Validation of Liquid Chromatographic Method for Analysis of Tacrolimus in a Pharmaceutical Dosage Form
title_full Validation of Liquid Chromatographic Method for Analysis of Tacrolimus in a Pharmaceutical Dosage Form
title_fullStr Validation of Liquid Chromatographic Method for Analysis of Tacrolimus in a Pharmaceutical Dosage Form
title_full_unstemmed Validation of Liquid Chromatographic Method for Analysis of Tacrolimus in a Pharmaceutical Dosage Form
title_sort Validation of Liquid Chromatographic Method for Analysis of Tacrolimus in a Pharmaceutical Dosage Form
dc.creator.none.fl_str_mv Moyano, Maria Alejandra
Simionato, Laura Daniela
Pizzorno, Maria Teresa
Segall, Adriana Ines
author Moyano, Maria Alejandra
author_facet Moyano, Maria Alejandra
Simionato, Laura Daniela
Pizzorno, Maria Teresa
Segall, Adriana Ines
author_role author
author2 Simionato, Laura Daniela
Pizzorno, Maria Teresa
Segall, Adriana Ines
author2_role author
author
author
dc.subject.none.fl_str_mv Tacrolimus
HPLC
Validation
topic Tacrolimus
HPLC
Validation
purl_subject.fl_str_mv https://purl.org/becyt/ford/3.1
https://purl.org/becyt/ford/3
dc.description.none.fl_txt_mv An accurate, simple and reproducible liquid chromatographic method was developed and validated for the determination of  tacrolimus in capsules. The analysis were performed at room temperature on a reverse phase C18 column with UV detection at 210 nm. The mobile phase consisted of  methanol-water (90 + 10) at a constant flow rate of 0.8 mL/min. The method was validated in terms of linearity, precision, accuracy and specificity by forced decomposition of tacrolimus using acid, base, water, hydrogen peroxide, heat and light. The response was linear in the range of 0.09-0.24  mg/mL (r2 = 0.9997). The relative standard deviation values for intra- and interday precision studies were 1.28 and 2.91.  Recoveries ranged between 98.06 and 102.52 %.
Fil: Moyano, Maria Alejandra. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica; Argentina
Fil: Simionato, Laura Daniela. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica; Argentina
Fil: Pizzorno, Maria Teresa. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay; Argentina
Fil: Segall, Adriana Ines. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica; Argentina
description An accurate, simple and reproducible liquid chromatographic method was developed and validated for the determination of  tacrolimus in capsules. The analysis were performed at room temperature on a reverse phase C18 column with UV detection at 210 nm. The mobile phase consisted of  methanol-water (90 + 10) at a constant flow rate of 0.8 mL/min. The method was validated in terms of linearity, precision, accuracy and specificity by forced decomposition of tacrolimus using acid, base, water, hydrogen peroxide, heat and light. The response was linear in the range of 0.09-0.24  mg/mL (r2 = 0.9997). The relative standard deviation values for intra- and interday precision studies were 1.28 and 2.91.  Recoveries ranged between 98.06 and 102.52 %.
publishDate 2006
dc.date.none.fl_str_mv 2006-12
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/11336/111469
Moyano, Maria Alejandra; Simionato, Laura Daniela; Pizzorno, Maria Teresa; Segall, Adriana Ines; Validation of Liquid Chromatographic Method for Analysis of Tacrolimus in a Pharmaceutical Dosage Form; AOAC International; Journal of AOAC International; 89; 12-2006; 1547-1551
1060-3271
CONICET Digital
CONICET
url http://hdl.handle.net/11336/111469
identifier_str_mv Moyano, Maria Alejandra; Simionato, Laura Daniela; Pizzorno, Maria Teresa; Segall, Adriana Ines; Validation of Liquid Chromatographic Method for Analysis of Tacrolimus in a Pharmaceutical Dosage Form; AOAC International; Journal of AOAC International; 89; 12-2006; 1547-1551
1060-3271
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://pubmed.ncbi.nlm.nih.gov/17225600/
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 AOAC International
publisher.none.fl_str_mv AOAC International
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
_version_ 1842268943030419456
score 12.885934

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