Development and validation of a LC-UV Method Applied to the Quality Control of Ursodeoxycholic Acid in Raw Material and Pharmaceutical Formulations

Autores
Boscolo, Oriana; Flor, Sabrina Andrea; Dobrecky, Cecilia Beatriz; Salvo, Lucila; Tripodi, Valeria Paula; Lucangioli, Silvia Edith
Año de publicación
2017
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
A simple, fast, and sensitive HPLC method with UV detection has been developed for the quantitation of ursodeoxycholic acid (UDCA) in raw material and pharmaceutical formulation (suspension). Cromatographic conditions were: Symmetry-C18 column (150 mm x 4.6 mm, id; particle size 5 µm), 40 ˚C, 100 µL injection volume and UV detection at 200 nm. The flow rate was 1 ml/min using acetonitrile - phosphoric acid (pH 3.0; 0.15mM) (48:52) as mobile phase. The method was validated according to international guidelines (ICH guidelines) for specificity, linearity, LOD, LOQ, precision, accuracy, and robustness. The HPLC-UV method was found to be suitable for the quality control of UDCA raw material and pharmaceutical formulation.
Fil: Boscolo, Oriana. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina
Fil: Flor, Sabrina Andrea. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Química Analítica y Fisicoquímica; Argentina
Fil: Dobrecky, Cecilia Beatriz. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Farmacología; Argentina
Fil: Salvo, Lucila. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina
Fil: Tripodi, Valeria Paula. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Farmacología; Argentina
Fil: Lucangioli, Silvia Edith. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Farmacología; Argentina
Materia
URSODEOXICHOLIC ACID
HPLC-UV
QUALITY CONTROL
PHARMACEUTICAL FORMULATION
RAW MATERIAL
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:11336/156558
Acceder
id CONICETDig_904290af85c2778e1f62b7b9f35bcfce
oai_identifier_str oai:ri.conicet.gov.ar:11336/156558
network_acronym_str CONICETDig
repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling Development and validation of a LC-UV Method Applied to the Quality Control of Ursodeoxycholic Acid in Raw Material and Pharmaceutical FormulationsBoscolo, OrianaFlor, Sabrina AndreaDobrecky, Cecilia BeatrizSalvo, LucilaTripodi, Valeria PaulaLucangioli, Silvia EdithURSODEOXICHOLIC ACIDHPLC-UVQUALITY CONTROLPHARMACEUTICAL FORMULATIONRAW MATERIALhttps://purl.org/becyt/ford/1.4https://purl.org/becyt/ford/1A simple, fast, and sensitive HPLC method with UV detection has been developed for the quantitation of ursodeoxycholic acid (UDCA) in raw material and pharmaceutical formulation (suspension). Cromatographic conditions were: Symmetry-C18 column (150 mm x 4.6 mm, id; particle size 5 µm), 40 ˚C, 100 µL injection volume and UV detection at 200 nm. The flow rate was 1 ml/min using acetonitrile - phosphoric acid (pH 3.0; 0.15mM) (48:52) as mobile phase. The method was validated according to international guidelines (ICH guidelines) for specificity, linearity, LOD, LOQ, precision, accuracy, and robustness. The HPLC-UV method was found to be suitable for the quality control of UDCA raw material and pharmaceutical formulation.Fil: Boscolo, Oriana. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; ArgentinaFil: Flor, Sabrina Andrea. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Química Analítica y Fisicoquímica; ArgentinaFil: Dobrecky, Cecilia Beatriz. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Farmacología; ArgentinaFil: Salvo, Lucila. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; ArgentinaFil: Tripodi, Valeria Paula. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Farmacología; ArgentinaFil: Lucangioli, Silvia Edith. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Farmacología; ArgentinaInternational Organization of Scientific Research2017-02info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfapplication/pdfapplication/pdfapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/156558Boscolo, Oriana; Flor, Sabrina Andrea; Dobrecky, Cecilia Beatriz; Salvo, Lucila; Tripodi, Valeria Paula; et al.; Development and validation of a LC-UV Method Applied to the Quality Control of Ursodeoxycholic Acid in Raw Material and Pharmaceutical Formulations; International Organization of Scientific Research; IOSR Journal of Pharmacy; 7; 2; 2-2017; 111-1162319-42192250-3013CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/http://www.iosrphr.org/pages/volume7-issue2.htmlinfo:eu-repo/semantics/altIdentifier/doi/10.9790/3013-070201111116info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-29T09:53:44Zoai:ri.conicet.gov.ar:11336/156558instacron: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 09:53:44.564CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Development and validation of a LC-UV Method Applied to the Quality Control of Ursodeoxycholic Acid in Raw Material and Pharmaceutical Formulations
title Development and validation of a LC-UV Method Applied to the Quality Control of Ursodeoxycholic Acid in Raw Material and Pharmaceutical Formulations
spellingShingle Development and validation of a LC-UV Method Applied to the Quality Control of Ursodeoxycholic Acid in Raw Material and Pharmaceutical Formulations
Boscolo, Oriana
URSODEOXICHOLIC ACID
HPLC-UV
QUALITY CONTROL
PHARMACEUTICAL FORMULATION
RAW MATERIAL
title_short Development and validation of a LC-UV Method Applied to the Quality Control of Ursodeoxycholic Acid in Raw Material and Pharmaceutical Formulations
title_full Development and validation of a LC-UV Method Applied to the Quality Control of Ursodeoxycholic Acid in Raw Material and Pharmaceutical Formulations
title_fullStr Development and validation of a LC-UV Method Applied to the Quality Control of Ursodeoxycholic Acid in Raw Material and Pharmaceutical Formulations
title_full_unstemmed Development and validation of a LC-UV Method Applied to the Quality Control of Ursodeoxycholic Acid in Raw Material and Pharmaceutical Formulations
title_sort Development and validation of a LC-UV Method Applied to the Quality Control of Ursodeoxycholic Acid in Raw Material and Pharmaceutical Formulations
dc.creator.none.fl_str_mv Boscolo, Oriana
Flor, Sabrina Andrea
Dobrecky, Cecilia Beatriz
Salvo, Lucila
Tripodi, Valeria Paula
Lucangioli, Silvia Edith
author Boscolo, Oriana
author_facet Boscolo, Oriana
Flor, Sabrina Andrea
Dobrecky, Cecilia Beatriz
Salvo, Lucila
Tripodi, Valeria Paula
Lucangioli, Silvia Edith
author_role author
author2 Flor, Sabrina Andrea
Dobrecky, Cecilia Beatriz
Salvo, Lucila
Tripodi, Valeria Paula
Lucangioli, Silvia Edith
author2_role author
author
author
author
author
dc.subject.none.fl_str_mv URSODEOXICHOLIC ACID
HPLC-UV
QUALITY CONTROL
PHARMACEUTICAL FORMULATION
RAW MATERIAL
topic URSODEOXICHOLIC ACID
HPLC-UV
QUALITY CONTROL
PHARMACEUTICAL FORMULATION
RAW MATERIAL
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 simple, fast, and sensitive HPLC method with UV detection has been developed for the quantitation of ursodeoxycholic acid (UDCA) in raw material and pharmaceutical formulation (suspension). Cromatographic conditions were: Symmetry-C18 column (150 mm x 4.6 mm, id; particle size 5 µm), 40 ˚C, 100 µL injection volume and UV detection at 200 nm. The flow rate was 1 ml/min using acetonitrile - phosphoric acid (pH 3.0; 0.15mM) (48:52) as mobile phase. The method was validated according to international guidelines (ICH guidelines) for specificity, linearity, LOD, LOQ, precision, accuracy, and robustness. The HPLC-UV method was found to be suitable for the quality control of UDCA raw material and pharmaceutical formulation.
Fil: Boscolo, Oriana. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina
Fil: Flor, Sabrina Andrea. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Química Analítica y Fisicoquímica; Argentina
Fil: Dobrecky, Cecilia Beatriz. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Farmacología; Argentina
Fil: Salvo, Lucila. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina
Fil: Tripodi, Valeria Paula. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Farmacología; Argentina
Fil: Lucangioli, Silvia Edith. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Farmacología; Argentina
description A simple, fast, and sensitive HPLC method with UV detection has been developed for the quantitation of ursodeoxycholic acid (UDCA) in raw material and pharmaceutical formulation (suspension). Cromatographic conditions were: Symmetry-C18 column (150 mm x 4.6 mm, id; particle size 5 µm), 40 ˚C, 100 µL injection volume and UV detection at 200 nm. The flow rate was 1 ml/min using acetonitrile - phosphoric acid (pH 3.0; 0.15mM) (48:52) as mobile phase. The method was validated according to international guidelines (ICH guidelines) for specificity, linearity, LOD, LOQ, precision, accuracy, and robustness. The HPLC-UV method was found to be suitable for the quality control of UDCA raw material and pharmaceutical formulation.
publishDate 2017
dc.date.none.fl_str_mv 2017-02
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/11336/156558
Boscolo, Oriana; Flor, Sabrina Andrea; Dobrecky, Cecilia Beatriz; Salvo, Lucila; Tripodi, Valeria Paula; et al.; Development and validation of a LC-UV Method Applied to the Quality Control of Ursodeoxycholic Acid in Raw Material and Pharmaceutical Formulations; International Organization of Scientific Research; IOSR Journal of Pharmacy; 7; 2; 2-2017; 111-116
2319-4219
2250-3013
CONICET Digital
CONICET
url http://hdl.handle.net/11336/156558
identifier_str_mv Boscolo, Oriana; Flor, Sabrina Andrea; Dobrecky, Cecilia Beatriz; Salvo, Lucila; Tripodi, Valeria Paula; et al.; Development and validation of a LC-UV Method Applied to the Quality Control of Ursodeoxycholic Acid in Raw Material and Pharmaceutical Formulations; International Organization of Scientific Research; IOSR Journal of Pharmacy; 7; 2; 2-2017; 111-116
2319-4219
2250-3013
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.iosrphr.org/pages/volume7-issue2.html
info:eu-repo/semantics/altIdentifier/doi/10.9790/3013-070201111116
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
dc.publisher.none.fl_str_mv International Organization of Scientific Research
publisher.none.fl_str_mv International Organization of Scientific Research
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_ 1844613638021709824
score 13.070432

Publicaciones similares