Stress testing of valsartan: Development and validation of a high performance liquid chromatography stability-indicating assay

Autores
Bianchini, Romina Marcela; Castellano, Patricia Margarita; Kaufman, Teodoro Saul
Año de publicación
2012
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
Stress testing studies were carried out on Valsartan (VAL) under hydrolytic (acidic, basic, and neutral), photolytic, oxidative, and thermal (in the solid state) conditions. Relevant degradation was observed when the drug was exposed to photolytic conditions, where two degradants (DP-1 and DP-2) were produced and when submitted to acid hydrolysis, which yielded one degradation product (DP-3). A high performance liquid chromatography method for the simultaneous determination of VAL and its degradation products was developed, optimized employing experimental design strategies, and validated, employing fully characterized standards of the degradation products. The results proved the stability-indicating property of the method.
Fil: Bianchini, Romina Marcela. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Rosario. Instituto de Química Rosario. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Instituto de Química Rosario; Argentina
Fil: Castellano, Patricia Margarita. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Rosario. Instituto de Química Rosario. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Instituto de Química Rosario; Argentina
Fil: Kaufman, Teodoro Saul. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Rosario. Instituto de Química Rosario. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Instituto de Química Rosario; Argentina
Materia
VALSARTAN
STRESS TESTING
STABILITY-INDICATING METHOD
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:11336/108009
Acceder
id CONICETDig_cf605b4e239c77aecaf532e27670d603
oai_identifier_str oai:ri.conicet.gov.ar:11336/108009
network_acronym_str CONICETDig
repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling Stress testing of valsartan: Development and validation of a high performance liquid chromatography stability-indicating assayBianchini, Romina MarcelaCastellano, Patricia MargaritaKaufman, Teodoro SaulVALSARTANSTRESS TESTINGSTABILITY-INDICATING METHODhttps://purl.org/becyt/ford/1.4https://purl.org/becyt/ford/1Stress testing studies were carried out on Valsartan (VAL) under hydrolytic (acidic, basic, and neutral), photolytic, oxidative, and thermal (in the solid state) conditions. Relevant degradation was observed when the drug was exposed to photolytic conditions, where two degradants (DP-1 and DP-2) were produced and when submitted to acid hydrolysis, which yielded one degradation product (DP-3). A high performance liquid chromatography method for the simultaneous determination of VAL and its degradation products was developed, optimized employing experimental design strategies, and validated, employing fully characterized standards of the degradation products. The results proved the stability-indicating property of the method.Fil: Bianchini, Romina Marcela. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Rosario. Instituto de Química Rosario. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Instituto de Química Rosario; ArgentinaFil: Castellano, Patricia Margarita. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Rosario. Instituto de Química Rosario. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Instituto de Química Rosario; ArgentinaFil: Kaufman, Teodoro Saul. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Rosario. Instituto de Química Rosario. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Instituto de Química Rosario; ArgentinaTaylor & Francis2012-04info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/108009Bianchini, Romina Marcela; Castellano, Patricia Margarita; Kaufman, Teodoro Saul; Stress testing of valsartan: Development and validation of a high performance liquid chromatography stability-indicating assay; Taylor & Francis; Journal of Liquid Chromatography and Related Technologies; 35; 8; 4-2012; 1053-10691082-6076CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/https://www.tandfonline.com/doi/abs/10.1080/10826076.2011.615094info:eu-repo/semantics/altIdentifier/doi/10.1080/10826076.2011.615094info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-03T09:52:08Zoai:ri.conicet.gov.ar:11336/108009instacron: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:34982025-09-03 09:52:08.497CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Stress testing of valsartan: Development and validation of a high performance liquid chromatography stability-indicating assay
title Stress testing of valsartan: Development and validation of a high performance liquid chromatography stability-indicating assay
spellingShingle Stress testing of valsartan: Development and validation of a high performance liquid chromatography stability-indicating assay
Bianchini, Romina Marcela
VALSARTAN
STRESS TESTING
STABILITY-INDICATING METHOD
title_short Stress testing of valsartan: Development and validation of a high performance liquid chromatography stability-indicating assay
title_full Stress testing of valsartan: Development and validation of a high performance liquid chromatography stability-indicating assay
title_fullStr Stress testing of valsartan: Development and validation of a high performance liquid chromatography stability-indicating assay
title_full_unstemmed Stress testing of valsartan: Development and validation of a high performance liquid chromatography stability-indicating assay
title_sort Stress testing of valsartan: Development and validation of a high performance liquid chromatography stability-indicating assay
dc.creator.none.fl_str_mv Bianchini, Romina Marcela
Castellano, Patricia Margarita
Kaufman, Teodoro Saul
author Bianchini, Romina Marcela
author_facet Bianchini, Romina Marcela
Castellano, Patricia Margarita
Kaufman, Teodoro Saul
author_role author
author2 Castellano, Patricia Margarita
Kaufman, Teodoro Saul
author2_role author
author
dc.subject.none.fl_str_mv VALSARTAN
STRESS TESTING
STABILITY-INDICATING METHOD
topic VALSARTAN
STRESS TESTING
STABILITY-INDICATING METHOD
purl_subject.fl_str_mv https://purl.org/becyt/ford/1.4
https://purl.org/becyt/ford/1
dc.description.none.fl_txt_mv Stress testing studies were carried out on Valsartan (VAL) under hydrolytic (acidic, basic, and neutral), photolytic, oxidative, and thermal (in the solid state) conditions. Relevant degradation was observed when the drug was exposed to photolytic conditions, where two degradants (DP-1 and DP-2) were produced and when submitted to acid hydrolysis, which yielded one degradation product (DP-3). A high performance liquid chromatography method for the simultaneous determination of VAL and its degradation products was developed, optimized employing experimental design strategies, and validated, employing fully characterized standards of the degradation products. The results proved the stability-indicating property of the method.
Fil: Bianchini, Romina Marcela. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Rosario. Instituto de Química Rosario. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Instituto de Química Rosario; Argentina
Fil: Castellano, Patricia Margarita. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Rosario. Instituto de Química Rosario. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Instituto de Química Rosario; Argentina
Fil: Kaufman, Teodoro Saul. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Rosario. Instituto de Química Rosario. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Instituto de Química Rosario; Argentina
description Stress testing studies were carried out on Valsartan (VAL) under hydrolytic (acidic, basic, and neutral), photolytic, oxidative, and thermal (in the solid state) conditions. Relevant degradation was observed when the drug was exposed to photolytic conditions, where two degradants (DP-1 and DP-2) were produced and when submitted to acid hydrolysis, which yielded one degradation product (DP-3). A high performance liquid chromatography method for the simultaneous determination of VAL and its degradation products was developed, optimized employing experimental design strategies, and validated, employing fully characterized standards of the degradation products. The results proved the stability-indicating property of the method.
publishDate 2012
dc.date.none.fl_str_mv 2012-04
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/11336/108009
Bianchini, Romina Marcela; Castellano, Patricia Margarita; Kaufman, Teodoro Saul; Stress testing of valsartan: Development and validation of a high performance liquid chromatography stability-indicating assay; Taylor & Francis; Journal of Liquid Chromatography and Related Technologies; 35; 8; 4-2012; 1053-1069
1082-6076
CONICET Digital
CONICET
url http://hdl.handle.net/11336/108009
identifier_str_mv Bianchini, Romina Marcela; Castellano, Patricia Margarita; Kaufman, Teodoro Saul; Stress testing of valsartan: Development and validation of a high performance liquid chromatography stability-indicating assay; Taylor & Francis; Journal of Liquid Chromatography and Related Technologies; 35; 8; 4-2012; 1053-1069
1082-6076
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://www.tandfonline.com/doi/abs/10.1080/10826076.2011.615094
info:eu-repo/semantics/altIdentifier/doi/10.1080/10826076.2011.615094
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
dc.publisher.none.fl_str_mv Taylor & Francis
publisher.none.fl_str_mv Taylor & Francis
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_ 1842269138455625728
score 13.13397

Publicaciones similares