Dissolution testing of ursodeoxycholic acid suspension using SPE as sample preparation

Autores
Boscolo, Oriana; Flores, Silvia Karina; Dobrecky, Cecilia Beatriz; Tripodi, Valeria Paula; Lucangioli, Silvia Edith
Año de publicación
2023
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
Objectives: To develop and validate an analytical method by HPLC?UV (High Performance Liquid Chromatography?Ultraviolet) for the quantification of ursodeoxycholic acid suspension in a dissolution test followed by a solid phase extraction (SPE) to circumvent the interference of sodiumlauryl sulphate (SLS) present in the dissolution medium.Methods: United States Pharmacopeia (USP) apparatus 2. The dissolution medium was 900 ml of an aqueous solution of 0.05 M phosphatebuffer (pH 8.4) with 2% SLS. The samples were filtered and cleaned by SPE with 500 mg/3ml C18 cartridges. The analytical method wasvalidated for specificity, linearity, LOD (limit of detection), LOQ (limit of quantification) accuracy and precision. Chromatographic conditions,Symmetry-C18 column (150 mm × 4.6 mm, id; 5 µm particle size), 40°C, 100 µl injection volume and UV detection at 200 nm. The flow rate was1 ml/min using acetonitrile?phosphoric acid (pH 3.0, 0.15 mM) (48:52).Key findings: SPE provided an efficient and selective extraction of ursodeoxycholic acid from the dissolution medium. On the other hand, theSPE washing step allowed the elimination of SLS. The ursodeoxycholic acid method optimisation and validation were accomplished with no lessthan 80% in 30 min.Conclusion: The developed analytical method was simple and adequate for the analysis of ursodeoxycholic acid suspension samples that metthe USP specifications for dissolution test.
Fil: Boscolo, Oriana. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina
Fil: Flores, Silvia Karina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: Dobrecky, Cecilia Beatriz. 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; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina
Fil: Lucangioli, Silvia Edith. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina
Materia
URSODEOXYCHOLIC ACID
SUSPENSION
DISSOLUTION
SOLID PHASE EXTRACTION
HPLC-UV
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:11336/225497
Acceder
id CONICETDig_e7ded66cce80bd11652a6860b0b8f599
oai_identifier_str oai:ri.conicet.gov.ar:11336/225497
network_acronym_str CONICETDig
repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling Dissolution testing of ursodeoxycholic acid suspension using SPE as sample preparationBoscolo, OrianaFlores, Silvia KarinaDobrecky, Cecilia BeatrizTripodi, Valeria PaulaLucangioli, Silvia EdithURSODEOXYCHOLIC ACIDSUSPENSIONDISSOLUTIONSOLID PHASE EXTRACTIONHPLC-UVhttps://purl.org/becyt/ford/3.3https://purl.org/becyt/ford/3Objectives: To develop and validate an analytical method by HPLC?UV (High Performance Liquid Chromatography?Ultraviolet) for the quantification of ursodeoxycholic acid suspension in a dissolution test followed by a solid phase extraction (SPE) to circumvent the interference of sodiumlauryl sulphate (SLS) present in the dissolution medium.Methods: United States Pharmacopeia (USP) apparatus 2. The dissolution medium was 900 ml of an aqueous solution of 0.05 M phosphatebuffer (pH 8.4) with 2% SLS. The samples were filtered and cleaned by SPE with 500 mg/3ml C18 cartridges. The analytical method wasvalidated for specificity, linearity, LOD (limit of detection), LOQ (limit of quantification) accuracy and precision. Chromatographic conditions,Symmetry-C18 column (150 mm × 4.6 mm, id; 5 µm particle size), 40°C, 100 µl injection volume and UV detection at 200 nm. The flow rate was1 ml/min using acetonitrile?phosphoric acid (pH 3.0, 0.15 mM) (48:52).Key findings: SPE provided an efficient and selective extraction of ursodeoxycholic acid from the dissolution medium. On the other hand, theSPE washing step allowed the elimination of SLS. The ursodeoxycholic acid method optimisation and validation were accomplished with no lessthan 80% in 30 min.Conclusion: The developed analytical method was simple and adequate for the analysis of ursodeoxycholic acid suspension samples that metthe USP specifications for dissolution test.Fil: Boscolo, Oriana. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; ArgentinaFil: Flores, Silvia Karina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Dobrecky, Cecilia Beatriz. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; 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. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; ArgentinaOxford University Press2023-12-01info: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/11336/225497Boscolo, Oriana; Flores, Silvia Karina; Dobrecky, Cecilia Beatriz; Tripodi, Valeria Paula; Lucangioli, Silvia Edith; Dissolution testing of ursodeoxycholic acid suspension using SPE as sample preparation; Oxford University Press; RPS Pharmacy and Pharmacology Reports; 2; 1; 1-12-2023; 1-52754-5849CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/https://academic.oup.com/rpsppr/article/doi/10.1093/rpsppr/rqac006/6855691info:eu-repo/semantics/altIdentifier/doi/10.1093/rpsppr/rqac006info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-10-22T11:35:06Zoai:ri.conicet.gov.ar:11336/225497instacron: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:34982025-10-22 11:35:07.221CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Dissolution testing of ursodeoxycholic acid suspension using SPE as sample preparation
title Dissolution testing of ursodeoxycholic acid suspension using SPE as sample preparation
spellingShingle Dissolution testing of ursodeoxycholic acid suspension using SPE as sample preparation
Boscolo, Oriana
URSODEOXYCHOLIC ACID
SUSPENSION
DISSOLUTION
SOLID PHASE EXTRACTION
HPLC-UV
title_short Dissolution testing of ursodeoxycholic acid suspension using SPE as sample preparation
title_full Dissolution testing of ursodeoxycholic acid suspension using SPE as sample preparation
title_fullStr Dissolution testing of ursodeoxycholic acid suspension using SPE as sample preparation
title_full_unstemmed Dissolution testing of ursodeoxycholic acid suspension using SPE as sample preparation
title_sort Dissolution testing of ursodeoxycholic acid suspension using SPE as sample preparation
dc.creator.none.fl_str_mv Boscolo, Oriana
Flores, Silvia Karina
Dobrecky, Cecilia Beatriz
Tripodi, Valeria Paula
Lucangioli, Silvia Edith
author Boscolo, Oriana
author_facet Boscolo, Oriana
Flores, Silvia Karina
Dobrecky, Cecilia Beatriz
Tripodi, Valeria Paula
Lucangioli, Silvia Edith
author_role author
author2 Flores, Silvia Karina
Dobrecky, Cecilia Beatriz
Tripodi, Valeria Paula
Lucangioli, Silvia Edith
author2_role author
author
author
author
dc.subject.none.fl_str_mv URSODEOXYCHOLIC ACID
SUSPENSION
DISSOLUTION
SOLID PHASE EXTRACTION
HPLC-UV
topic URSODEOXYCHOLIC ACID
SUSPENSION
DISSOLUTION
SOLID PHASE EXTRACTION
HPLC-UV
purl_subject.fl_str_mv https://purl.org/becyt/ford/3.3
https://purl.org/becyt/ford/3
dc.description.none.fl_txt_mv Objectives: To develop and validate an analytical method by HPLC?UV (High Performance Liquid Chromatography?Ultraviolet) for the quantification of ursodeoxycholic acid suspension in a dissolution test followed by a solid phase extraction (SPE) to circumvent the interference of sodiumlauryl sulphate (SLS) present in the dissolution medium.Methods: United States Pharmacopeia (USP) apparatus 2. The dissolution medium was 900 ml of an aqueous solution of 0.05 M phosphatebuffer (pH 8.4) with 2% SLS. The samples were filtered and cleaned by SPE with 500 mg/3ml C18 cartridges. The analytical method wasvalidated for specificity, linearity, LOD (limit of detection), LOQ (limit of quantification) accuracy and precision. Chromatographic conditions,Symmetry-C18 column (150 mm × 4.6 mm, id; 5 µm particle size), 40°C, 100 µl injection volume and UV detection at 200 nm. The flow rate was1 ml/min using acetonitrile?phosphoric acid (pH 3.0, 0.15 mM) (48:52).Key findings: SPE provided an efficient and selective extraction of ursodeoxycholic acid from the dissolution medium. On the other hand, theSPE washing step allowed the elimination of SLS. The ursodeoxycholic acid method optimisation and validation were accomplished with no lessthan 80% in 30 min.Conclusion: The developed analytical method was simple and adequate for the analysis of ursodeoxycholic acid suspension samples that metthe USP specifications for dissolution test.
Fil: Boscolo, Oriana. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina
Fil: Flores, Silvia Karina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: Dobrecky, Cecilia Beatriz. 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; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina
Fil: Lucangioli, Silvia Edith. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina
description Objectives: To develop and validate an analytical method by HPLC?UV (High Performance Liquid Chromatography?Ultraviolet) for the quantification of ursodeoxycholic acid suspension in a dissolution test followed by a solid phase extraction (SPE) to circumvent the interference of sodiumlauryl sulphate (SLS) present in the dissolution medium.Methods: United States Pharmacopeia (USP) apparatus 2. The dissolution medium was 900 ml of an aqueous solution of 0.05 M phosphatebuffer (pH 8.4) with 2% SLS. The samples were filtered and cleaned by SPE with 500 mg/3ml C18 cartridges. The analytical method wasvalidated for specificity, linearity, LOD (limit of detection), LOQ (limit of quantification) accuracy and precision. Chromatographic conditions,Symmetry-C18 column (150 mm × 4.6 mm, id; 5 µm particle size), 40°C, 100 µl injection volume and UV detection at 200 nm. The flow rate was1 ml/min using acetonitrile?phosphoric acid (pH 3.0, 0.15 mM) (48:52).Key findings: SPE provided an efficient and selective extraction of ursodeoxycholic acid from the dissolution medium. On the other hand, theSPE washing step allowed the elimination of SLS. The ursodeoxycholic acid method optimisation and validation were accomplished with no lessthan 80% in 30 min.Conclusion: The developed analytical method was simple and adequate for the analysis of ursodeoxycholic acid suspension samples that metthe USP specifications for dissolution test.
publishDate 2023
dc.date.none.fl_str_mv 2023-12-01
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/11336/225497
Boscolo, Oriana; Flores, Silvia Karina; Dobrecky, Cecilia Beatriz; Tripodi, Valeria Paula; Lucangioli, Silvia Edith; Dissolution testing of ursodeoxycholic acid suspension using SPE as sample preparation; Oxford University Press; RPS Pharmacy and Pharmacology Reports; 2; 1; 1-12-2023; 1-5
2754-5849
CONICET Digital
CONICET
url http://hdl.handle.net/11336/225497
identifier_str_mv Boscolo, Oriana; Flores, Silvia Karina; Dobrecky, Cecilia Beatriz; Tripodi, Valeria Paula; Lucangioli, Silvia Edith; Dissolution testing of ursodeoxycholic acid suspension using SPE as sample preparation; Oxford University Press; RPS Pharmacy and Pharmacology Reports; 2; 1; 1-12-2023; 1-5
2754-5849
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://academic.oup.com/rpsppr/article/doi/10.1093/rpsppr/rqac006/6855691
info:eu-repo/semantics/altIdentifier/doi/10.1093/rpsppr/rqac006
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 Oxford University Press
publisher.none.fl_str_mv Oxford University Press
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 12.982451

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