Validation of UV-Visible and HPLC method for the determination of sodium p-aminosalicylate and m-aminophenol in a new pharmaceutical formulation

Autores
Hergert, Lisandro Yamil; Ravetti, Soledad; Mazzieri, Maria Rosa
Año de publicación
2015
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
Sodium p-aminosalycilate is an orphan drug used in patients affected with multidrug-resistant Tuberculosis. Two methods, high-performance liquid chromatographic and ultraviolet spectrophotometric for the quantitative determination of sodium p-aminosalycilate and its degradation productm-aminophenol in a new pharmaceutical formulation, powder for extemporaneous reconstitution, were developed in the present work. The parameters linearity, precision, accuracy, specificity, robustness, limit of detection, and limit of quantification were also studied. Chromatography was carried out by reverse-phase technique on an RP-18 column with a mobile phase composed of 50 mM monobasic/dibasic phosphate buffer and methanol (42.5:42.5:15 v/v/v) with 1.9 g of hidroxytetrabutyl ammonium ionic pare adjusted to pH 7.0 with orthophosphoric acid. The ultraviolet spectrophotometric method was performed at 254 nm and 280 nm for quantification of sodium p-aminosalycilate and m-aminophenol, respectively. The proposed methods are highly sensitive, precise, and accurate and can be used for the reliable quantification of sodium p-aminosalycilate in the new alternative formulation. High-performance liquid chromatographic approach demonstrated to be a stability-indicating method, therefore suitable for the investigation of the chemical stability of sodium p-aminosalycilate.
Fil: Hergert, Lisandro Yamil. Universidad Nacional de Villa María. Instituto Académico Pedagógico de Ciencias Básicas y Aplicadas; Argentina. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Departamento de Farmacia; Argentina
Fil: Ravetti, Soledad. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Centro de Investigaciones y Transferencia de Villa María. Universidad Nacional de Villa María. Centro de Investigaciones y Transferencia de Villa María; Argentina
Fil: Mazzieri, Maria Rosa. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Departamento de Farmacia; Argentina
Materia
Sodium P-Aminosalycilate
M-Aminophenol
Hplc
Uv Spectrophotometry
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:11336/71770
Acceder
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oai_identifier_str oai:ri.conicet.gov.ar:11336/71770
network_acronym_str CONICETDig
repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling Validation of UV-Visible and HPLC method for the determination of sodium p-aminosalicylate and m-aminophenol in a new pharmaceutical formulationHergert, Lisandro YamilRavetti, SoledadMazzieri, Maria RosaSodium P-AminosalycilateM-AminophenolHplcUv Spectrophotometryhttps://purl.org/becyt/ford/1.4https://purl.org/becyt/ford/1Sodium p-aminosalycilate is an orphan drug used in patients affected with multidrug-resistant Tuberculosis. Two methods, high-performance liquid chromatographic and ultraviolet spectrophotometric for the quantitative determination of sodium p-aminosalycilate and its degradation productm-aminophenol in a new pharmaceutical formulation, powder for extemporaneous reconstitution, were developed in the present work. The parameters linearity, precision, accuracy, specificity, robustness, limit of detection, and limit of quantification were also studied. Chromatography was carried out by reverse-phase technique on an RP-18 column with a mobile phase composed of 50 mM monobasic/dibasic phosphate buffer and methanol (42.5:42.5:15 v/v/v) with 1.9 g of hidroxytetrabutyl ammonium ionic pare adjusted to pH 7.0 with orthophosphoric acid. The ultraviolet spectrophotometric method was performed at 254 nm and 280 nm for quantification of sodium p-aminosalycilate and m-aminophenol, respectively. The proposed methods are highly sensitive, precise, and accurate and can be used for the reliable quantification of sodium p-aminosalycilate in the new alternative formulation. High-performance liquid chromatographic approach demonstrated to be a stability-indicating method, therefore suitable for the investigation of the chemical stability of sodium p-aminosalycilate.Fil: Hergert, Lisandro Yamil. Universidad Nacional de Villa María. Instituto Académico Pedagógico de Ciencias Básicas y Aplicadas; Argentina. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Departamento de Farmacia; ArgentinaFil: Ravetti, Soledad. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Centro de Investigaciones y Transferencia de Villa María. Universidad Nacional de Villa María. Centro de Investigaciones y Transferencia de Villa María; ArgentinaFil: Mazzieri, Maria Rosa. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Departamento de Farmacia; ArgentinaInternational Journal of Pharmaceutical Compounding2015-12info: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/11336/71770Hergert, Lisandro Yamil; Ravetti, Soledad; Mazzieri, Maria Rosa; Validation of UV-Visible and HPLC method for the determination of sodium p-aminosalicylate and m-aminophenol in a new pharmaceutical formulation; International Journal of Pharmaceutical Compounding; International Journal Of Pharmaceutical Compounding; 20; 1; 12-2015; 63-701516-5140CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/https://www.ijpc.com/Abstracts/Abstract.cfm?ABS=4102info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-29T09:58:10Zoai:ri.conicet.gov.ar:11336/71770instacron: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 09:58:10.684CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Validation of UV-Visible and HPLC method for the determination of sodium p-aminosalicylate and m-aminophenol in a new pharmaceutical formulation
title Validation of UV-Visible and HPLC method for the determination of sodium p-aminosalicylate and m-aminophenol in a new pharmaceutical formulation
spellingShingle Validation of UV-Visible and HPLC method for the determination of sodium p-aminosalicylate and m-aminophenol in a new pharmaceutical formulation
Hergert, Lisandro Yamil
Sodium P-Aminosalycilate
M-Aminophenol
Hplc
Uv Spectrophotometry
title_short Validation of UV-Visible and HPLC method for the determination of sodium p-aminosalicylate and m-aminophenol in a new pharmaceutical formulation
title_full Validation of UV-Visible and HPLC method for the determination of sodium p-aminosalicylate and m-aminophenol in a new pharmaceutical formulation
title_fullStr Validation of UV-Visible and HPLC method for the determination of sodium p-aminosalicylate and m-aminophenol in a new pharmaceutical formulation
title_full_unstemmed Validation of UV-Visible and HPLC method for the determination of sodium p-aminosalicylate and m-aminophenol in a new pharmaceutical formulation
title_sort Validation of UV-Visible and HPLC method for the determination of sodium p-aminosalicylate and m-aminophenol in a new pharmaceutical formulation
dc.creator.none.fl_str_mv Hergert, Lisandro Yamil
Ravetti, Soledad
Mazzieri, Maria Rosa
author Hergert, Lisandro Yamil
author_facet Hergert, Lisandro Yamil
Ravetti, Soledad
Mazzieri, Maria Rosa
author_role author
author2 Ravetti, Soledad
Mazzieri, Maria Rosa
author2_role author
author
dc.subject.none.fl_str_mv Sodium P-Aminosalycilate
M-Aminophenol
Hplc
Uv Spectrophotometry
topic Sodium P-Aminosalycilate
M-Aminophenol
Hplc
Uv Spectrophotometry
purl_subject.fl_str_mv https://purl.org/becyt/ford/1.4
https://purl.org/becyt/ford/1
dc.description.none.fl_txt_mv Sodium p-aminosalycilate is an orphan drug used in patients affected with multidrug-resistant Tuberculosis. Two methods, high-performance liquid chromatographic and ultraviolet spectrophotometric for the quantitative determination of sodium p-aminosalycilate and its degradation productm-aminophenol in a new pharmaceutical formulation, powder for extemporaneous reconstitution, were developed in the present work. The parameters linearity, precision, accuracy, specificity, robustness, limit of detection, and limit of quantification were also studied. Chromatography was carried out by reverse-phase technique on an RP-18 column with a mobile phase composed of 50 mM monobasic/dibasic phosphate buffer and methanol (42.5:42.5:15 v/v/v) with 1.9 g of hidroxytetrabutyl ammonium ionic pare adjusted to pH 7.0 with orthophosphoric acid. The ultraviolet spectrophotometric method was performed at 254 nm and 280 nm for quantification of sodium p-aminosalycilate and m-aminophenol, respectively. The proposed methods are highly sensitive, precise, and accurate and can be used for the reliable quantification of sodium p-aminosalycilate in the new alternative formulation. High-performance liquid chromatographic approach demonstrated to be a stability-indicating method, therefore suitable for the investigation of the chemical stability of sodium p-aminosalycilate.
Fil: Hergert, Lisandro Yamil. Universidad Nacional de Villa María. Instituto Académico Pedagógico de Ciencias Básicas y Aplicadas; Argentina. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Departamento de Farmacia; Argentina
Fil: Ravetti, Soledad. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Centro de Investigaciones y Transferencia de Villa María. Universidad Nacional de Villa María. Centro de Investigaciones y Transferencia de Villa María; Argentina
Fil: Mazzieri, Maria Rosa. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Departamento de Farmacia; Argentina
description Sodium p-aminosalycilate is an orphan drug used in patients affected with multidrug-resistant Tuberculosis. Two methods, high-performance liquid chromatographic and ultraviolet spectrophotometric for the quantitative determination of sodium p-aminosalycilate and its degradation productm-aminophenol in a new pharmaceutical formulation, powder for extemporaneous reconstitution, were developed in the present work. The parameters linearity, precision, accuracy, specificity, robustness, limit of detection, and limit of quantification were also studied. Chromatography was carried out by reverse-phase technique on an RP-18 column with a mobile phase composed of 50 mM monobasic/dibasic phosphate buffer and methanol (42.5:42.5:15 v/v/v) with 1.9 g of hidroxytetrabutyl ammonium ionic pare adjusted to pH 7.0 with orthophosphoric acid. The ultraviolet spectrophotometric method was performed at 254 nm and 280 nm for quantification of sodium p-aminosalycilate and m-aminophenol, respectively. The proposed methods are highly sensitive, precise, and accurate and can be used for the reliable quantification of sodium p-aminosalycilate in the new alternative formulation. High-performance liquid chromatographic approach demonstrated to be a stability-indicating method, therefore suitable for the investigation of the chemical stability of sodium p-aminosalycilate.
publishDate 2015
dc.date.none.fl_str_mv 2015-12
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/11336/71770
Hergert, Lisandro Yamil; Ravetti, Soledad; Mazzieri, Maria Rosa; Validation of UV-Visible and HPLC method for the determination of sodium p-aminosalicylate and m-aminophenol in a new pharmaceutical formulation; International Journal of Pharmaceutical Compounding; International Journal Of Pharmaceutical Compounding; 20; 1; 12-2015; 63-70
1516-5140
CONICET Digital
CONICET
url http://hdl.handle.net/11336/71770
identifier_str_mv Hergert, Lisandro Yamil; Ravetti, Soledad; Mazzieri, Maria Rosa; Validation of UV-Visible and HPLC method for the determination of sodium p-aminosalicylate and m-aminophenol in a new pharmaceutical formulation; International Journal of Pharmaceutical Compounding; International Journal Of Pharmaceutical Compounding; 20; 1; 12-2015; 63-70
1516-5140
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.ijpc.com/Abstracts/Abstract.cfm?ABS=4102
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 International Journal of Pharmaceutical Compounding
publisher.none.fl_str_mv International Journal of Pharmaceutical Compounding
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 13.070432

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