LC-MS/MS Method Applied to the Detection and Quantification of Ursodeoxycholic Acid Related Substances in Raw Material and Pharmaceutical Formulation

Autores
Boscolo, Oriana; Flor, Sabrina Andrea; Dobrecky Ceciclia; Martinefski, Manuela Romina; Tripodi, Valeria Paula; Lucangioli, Silvia Edith
Año de publicación
2018
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
Abstract: Objective: To develop a highly sensitive LC-MS/MS (liquid chromatography-mass spectrometry/mass spectrometry)method applied to the detection and quantitation of UDCA (ursodeoxycholic acid) related substances such as CA (cholic acid), DCA(deoxycholic acid), CDCA (chenodeoxycholic acid) and LCA (lithocholic acid) in raw material and pharmaceutical formulation.Methods: The method was validated for specificity, linearity, accuracy, precision, robustness. A triple quadrupole mass detector wasemployed, equipped with an ESI (electrospray ionization) source operated in the negative ion mode. The chromatographic systemconsisted of a Symmetry C18 column (150 mm × 4.6 mm, id; particle size 5 µm) and methanol-acetonitrile-ammonium acetate (pH 7.6;10 mM) (40:40:20, v/v/v) as the mobile phase. The chromatographic conditions were 25 uL injection volume, flow rate of 0.4 mL/minand column temperature set at 35 °C. Key findings: The method requires a minimum sample amount and presents very low LOD(limits of detection) for CA (0.29 ng/mL), DCA (0.59 ng/mL), CDCA (0.13 ng/mL) and LCA (0.44 ng/mL) in comparison to LCmethods coupled to different detectors like UV (ultraviolet), fluorescence and refractive index. Conclusions: The developed andvalidated LC-MS/MS method for the determination of UDCA and related substances in raw material and in a suspension wasadvantageous since it required a minimum sample amount. In turn, it could be used as a stability indicating method.
Fil: Boscolo, Oriana. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay; Argentina
Fil: Flor, Sabrina Andrea. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Química Analítica y Fisicoquímica. Cátedra de Química Analítica; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay; Argentina
Fil: Dobrecky Ceciclia. 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: Martinefski, Manuela Romina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Química Analítica y Fisicoquímica. Cátedra de Química Analítica; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay; Argentina
Fil: Tripodi, Valeria Paula. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay; 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. Oficina de Coordinación Administrativa Houssay; Argentina
Materia
LC-MS/MS
URSODEOXYCHOLIC ACID
PHARMACEUTICAL FORMULATION
RAW MATERIAL
RELATED SUBSTANCES
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:11336/129815
Acceder
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oai_identifier_str oai:ri.conicet.gov.ar:11336/129815
network_acronym_str CONICETDig
repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling LC-MS/MS Method Applied to the Detection and Quantification of Ursodeoxycholic Acid Related Substances in Raw Material and Pharmaceutical FormulationBoscolo, OrianaFlor, Sabrina AndreaDobrecky CecicliaMartinefski, Manuela RominaTripodi, Valeria PaulaLucangioli, Silvia EdithLC-MS/MSURSODEOXYCHOLIC ACIDPHARMACEUTICAL FORMULATIONRAW MATERIALRELATED SUBSTANCEShttps://purl.org/becyt/ford/1.4https://purl.org/becyt/ford/1Abstract: Objective: To develop a highly sensitive LC-MS/MS (liquid chromatography-mass spectrometry/mass spectrometry)method applied to the detection and quantitation of UDCA (ursodeoxycholic acid) related substances such as CA (cholic acid), DCA(deoxycholic acid), CDCA (chenodeoxycholic acid) and LCA (lithocholic acid) in raw material and pharmaceutical formulation.Methods: The method was validated for specificity, linearity, accuracy, precision, robustness. A triple quadrupole mass detector wasemployed, equipped with an ESI (electrospray ionization) source operated in the negative ion mode. The chromatographic systemconsisted of a Symmetry C18 column (150 mm × 4.6 mm, id; particle size 5 µm) and methanol-acetonitrile-ammonium acetate (pH 7.6;10 mM) (40:40:20, v/v/v) as the mobile phase. The chromatographic conditions were 25 uL injection volume, flow rate of 0.4 mL/minand column temperature set at 35 °C. Key findings: The method requires a minimum sample amount and presents very low LOD(limits of detection) for CA (0.29 ng/mL), DCA (0.59 ng/mL), CDCA (0.13 ng/mL) and LCA (0.44 ng/mL) in comparison to LCmethods coupled to different detectors like UV (ultraviolet), fluorescence and refractive index. Conclusions: The developed andvalidated LC-MS/MS method for the determination of UDCA and related substances in raw material and in a suspension wasadvantageous since it required a minimum sample amount. In turn, it could be used as a stability indicating method.Fil: Boscolo, Oriana. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay; ArgentinaFil: Flor, Sabrina Andrea. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Química Analítica y Fisicoquímica. Cátedra de Química Analítica; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay; ArgentinaFil: Dobrecky Ceciclia. 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: Martinefski, Manuela Romina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Química Analítica y Fisicoquímica. Cátedra de Química Analítica; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay; ArgentinaFil: Tripodi, Valeria Paula. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay; 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. Oficina de Coordinación Administrativa Houssay; ArgentinaDavid Publishing2018-04info: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/11336/129815Boscolo, Oriana; Flor, Sabrina Andrea; Dobrecky Ceciclia; Martinefski, Manuela Romina; Tripodi, Valeria Paula; et al.; LC-MS/MS Method Applied to the Detection and Quantification of Ursodeoxycholic Acid Related Substances in Raw Material and Pharmaceutical Formulation; David Publishing; Journal of Pharmacy and Pharmacology; 5; 4-2018; 448-4552328-2150CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/http://www.davidpublisher.org/index.php/Home/Article/index?id=35406.htmlinfo:eu-repo/semantics/altIdentifier/doi/10.17265/2328-2150/2018.05.002info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-29T10:43:17Zoai:ri.conicet.gov.ar:11336/129815instacron: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 10:43:17.754CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv LC-MS/MS Method Applied to the Detection and Quantification of Ursodeoxycholic Acid Related Substances in Raw Material and Pharmaceutical Formulation
title LC-MS/MS Method Applied to the Detection and Quantification of Ursodeoxycholic Acid Related Substances in Raw Material and Pharmaceutical Formulation
spellingShingle LC-MS/MS Method Applied to the Detection and Quantification of Ursodeoxycholic Acid Related Substances in Raw Material and Pharmaceutical Formulation
Boscolo, Oriana
LC-MS/MS
URSODEOXYCHOLIC ACID
PHARMACEUTICAL FORMULATION
RAW MATERIAL
RELATED SUBSTANCES
title_short LC-MS/MS Method Applied to the Detection and Quantification of Ursodeoxycholic Acid Related Substances in Raw Material and Pharmaceutical Formulation
title_full LC-MS/MS Method Applied to the Detection and Quantification of Ursodeoxycholic Acid Related Substances in Raw Material and Pharmaceutical Formulation
title_fullStr LC-MS/MS Method Applied to the Detection and Quantification of Ursodeoxycholic Acid Related Substances in Raw Material and Pharmaceutical Formulation
title_full_unstemmed LC-MS/MS Method Applied to the Detection and Quantification of Ursodeoxycholic Acid Related Substances in Raw Material and Pharmaceutical Formulation
title_sort LC-MS/MS Method Applied to the Detection and Quantification of Ursodeoxycholic Acid Related Substances in Raw Material and Pharmaceutical Formulation
dc.creator.none.fl_str_mv Boscolo, Oriana
Flor, Sabrina Andrea
Dobrecky Ceciclia
Martinefski, Manuela Romina
Tripodi, Valeria Paula
Lucangioli, Silvia Edith
author Boscolo, Oriana
author_facet Boscolo, Oriana
Flor, Sabrina Andrea
Dobrecky Ceciclia
Martinefski, Manuela Romina
Tripodi, Valeria Paula
Lucangioli, Silvia Edith
author_role author
author2 Flor, Sabrina Andrea
Dobrecky Ceciclia
Martinefski, Manuela Romina
Tripodi, Valeria Paula
Lucangioli, Silvia Edith
author2_role author
author
author
author
author
dc.subject.none.fl_str_mv LC-MS/MS
URSODEOXYCHOLIC ACID
PHARMACEUTICAL FORMULATION
RAW MATERIAL
RELATED SUBSTANCES
topic LC-MS/MS
URSODEOXYCHOLIC ACID
PHARMACEUTICAL FORMULATION
RAW MATERIAL
RELATED SUBSTANCES
purl_subject.fl_str_mv https://purl.org/becyt/ford/1.4
https://purl.org/becyt/ford/1
dc.description.none.fl_txt_mv Abstract: Objective: To develop a highly sensitive LC-MS/MS (liquid chromatography-mass spectrometry/mass spectrometry)method applied to the detection and quantitation of UDCA (ursodeoxycholic acid) related substances such as CA (cholic acid), DCA(deoxycholic acid), CDCA (chenodeoxycholic acid) and LCA (lithocholic acid) in raw material and pharmaceutical formulation.Methods: The method was validated for specificity, linearity, accuracy, precision, robustness. A triple quadrupole mass detector wasemployed, equipped with an ESI (electrospray ionization) source operated in the negative ion mode. The chromatographic systemconsisted of a Symmetry C18 column (150 mm × 4.6 mm, id; particle size 5 µm) and methanol-acetonitrile-ammonium acetate (pH 7.6;10 mM) (40:40:20, v/v/v) as the mobile phase. The chromatographic conditions were 25 uL injection volume, flow rate of 0.4 mL/minand column temperature set at 35 °C. Key findings: The method requires a minimum sample amount and presents very low LOD(limits of detection) for CA (0.29 ng/mL), DCA (0.59 ng/mL), CDCA (0.13 ng/mL) and LCA (0.44 ng/mL) in comparison to LCmethods coupled to different detectors like UV (ultraviolet), fluorescence and refractive index. Conclusions: The developed andvalidated LC-MS/MS method for the determination of UDCA and related substances in raw material and in a suspension wasadvantageous since it required a minimum sample amount. In turn, it could be used as a stability indicating method.
Fil: Boscolo, Oriana. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay; Argentina
Fil: Flor, Sabrina Andrea. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Química Analítica y Fisicoquímica. Cátedra de Química Analítica; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay; Argentina
Fil: Dobrecky Ceciclia. 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: Martinefski, Manuela Romina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Química Analítica y Fisicoquímica. Cátedra de Química Analítica; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay; Argentina
Fil: Tripodi, Valeria Paula. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay; 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. Oficina de Coordinación Administrativa Houssay; Argentina
description Abstract: Objective: To develop a highly sensitive LC-MS/MS (liquid chromatography-mass spectrometry/mass spectrometry)method applied to the detection and quantitation of UDCA (ursodeoxycholic acid) related substances such as CA (cholic acid), DCA(deoxycholic acid), CDCA (chenodeoxycholic acid) and LCA (lithocholic acid) in raw material and pharmaceutical formulation.Methods: The method was validated for specificity, linearity, accuracy, precision, robustness. A triple quadrupole mass detector wasemployed, equipped with an ESI (electrospray ionization) source operated in the negative ion mode. The chromatographic systemconsisted of a Symmetry C18 column (150 mm × 4.6 mm, id; particle size 5 µm) and methanol-acetonitrile-ammonium acetate (pH 7.6;10 mM) (40:40:20, v/v/v) as the mobile phase. The chromatographic conditions were 25 uL injection volume, flow rate of 0.4 mL/minand column temperature set at 35 °C. Key findings: The method requires a minimum sample amount and presents very low LOD(limits of detection) for CA (0.29 ng/mL), DCA (0.59 ng/mL), CDCA (0.13 ng/mL) and LCA (0.44 ng/mL) in comparison to LCmethods coupled to different detectors like UV (ultraviolet), fluorescence and refractive index. Conclusions: The developed andvalidated LC-MS/MS method for the determination of UDCA and related substances in raw material and in a suspension wasadvantageous since it required a minimum sample amount. In turn, it could be used as a stability indicating method.
publishDate 2018
dc.date.none.fl_str_mv 2018-04
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/11336/129815
Boscolo, Oriana; Flor, Sabrina Andrea; Dobrecky Ceciclia; Martinefski, Manuela Romina; Tripodi, Valeria Paula; et al.; LC-MS/MS Method Applied to the Detection and Quantification of Ursodeoxycholic Acid Related Substances in Raw Material and Pharmaceutical Formulation; David Publishing; Journal of Pharmacy and Pharmacology; 5; 4-2018; 448-455
2328-2150
CONICET Digital
CONICET
url http://hdl.handle.net/11336/129815
identifier_str_mv Boscolo, Oriana; Flor, Sabrina Andrea; Dobrecky Ceciclia; Martinefski, Manuela Romina; Tripodi, Valeria Paula; et al.; LC-MS/MS Method Applied to the Detection and Quantification of Ursodeoxycholic Acid Related Substances in Raw Material and Pharmaceutical Formulation; David Publishing; Journal of Pharmacy and Pharmacology; 5; 4-2018; 448-455
2328-2150
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.davidpublisher.org/index.php/Home/Article/index?id=35406.html
info:eu-repo/semantics/altIdentifier/doi/10.17265/2328-2150/2018.05.002
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
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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
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application/pdf
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dc.publisher.none.fl_str_mv David Publishing
publisher.none.fl_str_mv David Publishing
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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