Development and validation of a highly sensitive HPLC method for determination of paclitaxel in pharmaceutical dosage forms and biological samples

Autores
Bernabeu, Ezequiel Adrian; Flor, Sabrina Andrea; Höcht, Christian; Taira, Carlos Alberto; Chiappetta, Diego Andrés; Tripodi, Valeria Paula; Lucangioli, Silvia Edith
Año de publicación
2014
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
A new simple and highly sensitive HPLC-UV method for the analysis of paclitaxel in Taxol® and Abraxane® has been developed which also allows the quantification in biological samples of pharmacokimnetic studies with a very easy sample preparation. The proposed method has advantages over previously reported methods, such as an increase in sensitivity up to 20 times, good accuracy in terms of recovery that allows to work without addition of internal standard and a simple sample preparation in one step. The analysis was carried out using a Zorbax Eclipse XDB-C18 (4.6 × 150 mm, 3.5 μm) with a column guard. The mobile phase consisted of acetonitrile: water (50: 50) and the flow rate was 1 mL/min, the detection wavelength was 227 nm, the injection volume 5 μL and the analysis was performed at room temperature. The method was validated according ICH guidelines and FDA guidelines for validation of bioanalytical methods. Linearity was evaluated in the range from 0.005 ? 50.0 μg/mL, with a regression coefficient (R2) of 0.9967. LOD and LOQ were 0.001 and 0.005 μg/mL respectively.
Fil: Bernabeu, Ezequiel Adrian. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: Flor, Sabrina Andrea. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Química Analítica y Fisicoquímica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: Höcht, Christian. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Farmacología; Argentina
Fil: Taira, Carlos Alberto. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Farmacología; Argentina
Fil: Chiappetta, Diego Andrés. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: Tripodi, Valeria Paula. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina
Fil: Lucangioli, Silvia Edith. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Materia
PACLITAXEL
HPLC-UV DETECTION
PHARMACEUTICAL FORMULATION
PHARMACOKINETIC STUDIES
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:11336/106618
Acceder
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oai_identifier_str oai:ri.conicet.gov.ar:11336/106618
network_acronym_str CONICETDig
repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling Development and validation of a highly sensitive HPLC method for determination of paclitaxel in pharmaceutical dosage forms and biological samplesBernabeu, Ezequiel AdrianFlor, Sabrina AndreaHöcht, ChristianTaira, Carlos AlbertoChiappetta, Diego AndrésTripodi, Valeria PaulaLucangioli, Silvia EdithPACLITAXELHPLC-UV DETECTIONPHARMACEUTICAL FORMULATIONPHARMACOKINETIC STUDIESVALIDATIONhttps://purl.org/becyt/ford/1.4https://purl.org/becyt/ford/1A new simple and highly sensitive HPLC-UV method for the analysis of paclitaxel in Taxol® and Abraxane® has been developed which also allows the quantification in biological samples of pharmacokimnetic studies with a very easy sample preparation. The proposed method has advantages over previously reported methods, such as an increase in sensitivity up to 20 times, good accuracy in terms of recovery that allows to work without addition of internal standard and a simple sample preparation in one step. The analysis was carried out using a Zorbax Eclipse XDB-C18 (4.6 × 150 mm, 3.5 μm) with a column guard. The mobile phase consisted of acetonitrile: water (50: 50) and the flow rate was 1 mL/min, the detection wavelength was 227 nm, the injection volume 5 μL and the analysis was performed at room temperature. The method was validated according ICH guidelines and FDA guidelines for validation of bioanalytical methods. Linearity was evaluated in the range from 0.005 ? 50.0 μg/mL, with a regression coefficient (R2) of 0.9967. LOD and LOQ were 0.001 and 0.005 μg/mL respectively.Fil: Bernabeu, Ezequiel Adrian. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Flor, Sabrina Andrea. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Química Analítica y Fisicoquímica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Höcht, Christian. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Farmacología; ArgentinaFil: Taira, Carlos Alberto. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Farmacología; ArgentinaFil: Chiappetta, Diego Andrés. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Tripodi, Valeria Paula. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; ArgentinaFil: Lucangioli, Silvia Edith. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaBentham Science Publishers2014-08info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfapplication/pdfapplication/pdfapplication/pdfapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/106618Bernabeu, Ezequiel Adrian; Flor, Sabrina Andrea; Höcht, Christian; Taira, Carlos Alberto; Chiappetta, Diego Andrés; et al.; Development and validation of a highly sensitive HPLC method for determination of paclitaxel in pharmaceutical dosage forms and biological samples; Bentham Science Publishers; Current Pharmaceutical Analysis; 10; 3; 8-2014; 185-1921573-4129CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/http://eurekaselect.com/121495info:eu-repo/semantics/altIdentifier/doi/10.2174/1573412910666140409002944info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-10-15T15:12:50Zoai:ri.conicet.gov.ar:11336/106618instacron: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:34982025-10-15 15:12:51.282CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Development and validation of a highly sensitive HPLC method for determination of paclitaxel in pharmaceutical dosage forms and biological samples
title Development and validation of a highly sensitive HPLC method for determination of paclitaxel in pharmaceutical dosage forms and biological samples
spellingShingle Development and validation of a highly sensitive HPLC method for determination of paclitaxel in pharmaceutical dosage forms and biological samples
Bernabeu, Ezequiel Adrian
PACLITAXEL
HPLC-UV DETECTION
PHARMACEUTICAL FORMULATION
PHARMACOKINETIC STUDIES
VALIDATION
title_short Development and validation of a highly sensitive HPLC method for determination of paclitaxel in pharmaceutical dosage forms and biological samples
title_full Development and validation of a highly sensitive HPLC method for determination of paclitaxel in pharmaceutical dosage forms and biological samples
title_fullStr Development and validation of a highly sensitive HPLC method for determination of paclitaxel in pharmaceutical dosage forms and biological samples
title_full_unstemmed Development and validation of a highly sensitive HPLC method for determination of paclitaxel in pharmaceutical dosage forms and biological samples
title_sort Development and validation of a highly sensitive HPLC method for determination of paclitaxel in pharmaceutical dosage forms and biological samples
dc.creator.none.fl_str_mv Bernabeu, Ezequiel Adrian
Flor, Sabrina Andrea
Höcht, Christian
Taira, Carlos Alberto
Chiappetta, Diego Andrés
Tripodi, Valeria Paula
Lucangioli, Silvia Edith
author Bernabeu, Ezequiel Adrian
author_facet Bernabeu, Ezequiel Adrian
Flor, Sabrina Andrea
Höcht, Christian
Taira, Carlos Alberto
Chiappetta, Diego Andrés
Tripodi, Valeria Paula
Lucangioli, Silvia Edith
author_role author
author2 Flor, Sabrina Andrea
Höcht, Christian
Taira, Carlos Alberto
Chiappetta, Diego Andrés
Tripodi, Valeria Paula
Lucangioli, Silvia Edith
author2_role author
author
author
author
author
author
dc.subject.none.fl_str_mv PACLITAXEL
HPLC-UV DETECTION
PHARMACEUTICAL FORMULATION
PHARMACOKINETIC STUDIES
VALIDATION
topic PACLITAXEL
HPLC-UV DETECTION
PHARMACEUTICAL FORMULATION
PHARMACOKINETIC STUDIES
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 A new simple and highly sensitive HPLC-UV method for the analysis of paclitaxel in Taxol® and Abraxane® has been developed which also allows the quantification in biological samples of pharmacokimnetic studies with a very easy sample preparation. The proposed method has advantages over previously reported methods, such as an increase in sensitivity up to 20 times, good accuracy in terms of recovery that allows to work without addition of internal standard and a simple sample preparation in one step. The analysis was carried out using a Zorbax Eclipse XDB-C18 (4.6 × 150 mm, 3.5 μm) with a column guard. The mobile phase consisted of acetonitrile: water (50: 50) and the flow rate was 1 mL/min, the detection wavelength was 227 nm, the injection volume 5 μL and the analysis was performed at room temperature. The method was validated according ICH guidelines and FDA guidelines for validation of bioanalytical methods. Linearity was evaluated in the range from 0.005 ? 50.0 μg/mL, with a regression coefficient (R2) of 0.9967. LOD and LOQ were 0.001 and 0.005 μg/mL respectively.
Fil: Bernabeu, Ezequiel Adrian. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: Flor, Sabrina Andrea. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Química Analítica y Fisicoquímica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: Höcht, Christian. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Farmacología; Argentina
Fil: Taira, Carlos Alberto. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Farmacología; Argentina
Fil: Chiappetta, Diego Andrés. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: Tripodi, Valeria Paula. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina
Fil: Lucangioli, Silvia Edith. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
description A new simple and highly sensitive HPLC-UV method for the analysis of paclitaxel in Taxol® and Abraxane® has been developed which also allows the quantification in biological samples of pharmacokimnetic studies with a very easy sample preparation. The proposed method has advantages over previously reported methods, such as an increase in sensitivity up to 20 times, good accuracy in terms of recovery that allows to work without addition of internal standard and a simple sample preparation in one step. The analysis was carried out using a Zorbax Eclipse XDB-C18 (4.6 × 150 mm, 3.5 μm) with a column guard. The mobile phase consisted of acetonitrile: water (50: 50) and the flow rate was 1 mL/min, the detection wavelength was 227 nm, the injection volume 5 μL and the analysis was performed at room temperature. The method was validated according ICH guidelines and FDA guidelines for validation of bioanalytical methods. Linearity was evaluated in the range from 0.005 ? 50.0 μg/mL, with a regression coefficient (R2) of 0.9967. LOD and LOQ were 0.001 and 0.005 μg/mL respectively.
publishDate 2014
dc.date.none.fl_str_mv 2014-08
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/11336/106618
Bernabeu, Ezequiel Adrian; Flor, Sabrina Andrea; Höcht, Christian; Taira, Carlos Alberto; Chiappetta, Diego Andrés; et al.; Development and validation of a highly sensitive HPLC method for determination of paclitaxel in pharmaceutical dosage forms and biological samples; Bentham Science Publishers; Current Pharmaceutical Analysis; 10; 3; 8-2014; 185-192
1573-4129
CONICET Digital
CONICET
url http://hdl.handle.net/11336/106618
identifier_str_mv Bernabeu, Ezequiel Adrian; Flor, Sabrina Andrea; Höcht, Christian; Taira, Carlos Alberto; Chiappetta, Diego Andrés; et al.; Development and validation of a highly sensitive HPLC method for determination of paclitaxel in pharmaceutical dosage forms and biological samples; Bentham Science Publishers; Current Pharmaceutical Analysis; 10; 3; 8-2014; 185-192
1573-4129
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://eurekaselect.com/121495
info:eu-repo/semantics/altIdentifier/doi/10.2174/1573412910666140409002944
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
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 13.22299

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