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
- Institución
- Consejo Nacional de Investigaciones Científicas y Técnicas
- OAI Identificador
- oai:ri.conicet.gov.ar:11336/225497
Ver los metadatos del registro completo
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network_name_str |
CONICET Digital (CONICET) |
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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 Técnicas2025-09-29T10:05:24Zoai: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:34982025-09-29 10:05:24.814CONICET 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 |
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CONICET Digital (CONICET) |
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CONICET Digital (CONICET) |
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Consejo Nacional de Investigaciones Científicas y Técnicas |
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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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1844613889917976576 |
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13.070432 |