Alternative and improved method for the simultaneous determination of fexofenadine and pseudoephedrine in their combined tablet formulation

Autores
Maggio, Ruben Mariano; Castellano, Patricia Margarita; Vignaduzzo, Silvana Edit; Kaufman, Teodoro Saul
Año de publicación
2007
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
An alternative method for the determination of fexofenadine (FEX) and pseudoephedrine (PSE) in their combined tablet formulation has been developed, employing the partial least squares (PLS) analysis of spectral data of the analytes in their pharmaceutical association. A full-factorially designed set of 16 synthetic samples was employed for calibration purposes. The calibration models were constructed with wavelengths selection, in the ultraviolet region, according to their predictive ability. These were validated internally by the leave-one-out procedure and externally, employing appropriate sets of validation samples. The described method was linear for both analytes, over the range 160.6-301.2 mg L-1 for FEX (R2 = 0.9993) and between 325.6 and 610.5 mg L-1 for PSE (R2 = 0.9992). It was accurate, exhibiting 99.8% and 99.9% drug recoveries for FEX and PSE, respectively (N = 9), while in the intermediate precision experiment relative standard deviations were 1.4% for FEX and 1.2% for PSE. The contents of both analytes were assayed in commercial tablets employing this method and the results were compared with those furnished by HPLC, being in good statistical agreement. The method represents an improvement over the first derivative of spectral ratio (DSR) technique and allows high sample throughput with minimum reagent consumption and waste generation. The obtained results confirm that the method is highly suitable for its intended purpose.
Fil: Maggio, Ruben Mariano. 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: Vignaduzzo, Silvana Edit. 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
CHEMOMETRIC DETERMINATION
FEXOFENADINE HYDROCHLORIDE
IMPROVED METHOD
PSEUDOEPHEDRINE HYDROCHLORIDE
TABLETS
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:11336/136552
Acceder
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network_acronym_str CONICETDig
repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling Alternative and improved method for the simultaneous determination of fexofenadine and pseudoephedrine in their combined tablet formulationMaggio, Ruben MarianoCastellano, Patricia MargaritaVignaduzzo, Silvana EditKaufman, Teodoro SaulCHEMOMETRIC DETERMINATIONFEXOFENADINE HYDROCHLORIDEIMPROVED METHODPSEUDOEPHEDRINE HYDROCHLORIDETABLETShttps://purl.org/becyt/ford/1.4https://purl.org/becyt/ford/1An alternative method for the determination of fexofenadine (FEX) and pseudoephedrine (PSE) in their combined tablet formulation has been developed, employing the partial least squares (PLS) analysis of spectral data of the analytes in their pharmaceutical association. A full-factorially designed set of 16 synthetic samples was employed for calibration purposes. The calibration models were constructed with wavelengths selection, in the ultraviolet region, according to their predictive ability. These were validated internally by the leave-one-out procedure and externally, employing appropriate sets of validation samples. The described method was linear for both analytes, over the range 160.6-301.2 mg L-1 for FEX (R2 = 0.9993) and between 325.6 and 610.5 mg L-1 for PSE (R2 = 0.9992). It was accurate, exhibiting 99.8% and 99.9% drug recoveries for FEX and PSE, respectively (N = 9), while in the intermediate precision experiment relative standard deviations were 1.4% for FEX and 1.2% for PSE. The contents of both analytes were assayed in commercial tablets employing this method and the results were compared with those furnished by HPLC, being in good statistical agreement. The method represents an improvement over the first derivative of spectral ratio (DSR) technique and allows high sample throughput with minimum reagent consumption and waste generation. The obtained results confirm that the method is highly suitable for its intended purpose.Fil: Maggio, Ruben Mariano. 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: Vignaduzzo, Silvana Edit. 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; ArgentinaElsevier Science2007-12info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfapplication/pdfapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/136552Maggio, Ruben Mariano; Castellano, Patricia Margarita; Vignaduzzo, Silvana Edit; Kaufman, Teodoro Saul; Alternative and improved method for the simultaneous determination of fexofenadine and pseudoephedrine in their combined tablet formulation; Elsevier Science; Journal of Pharmaceutical and Biomedical Analysis; 45; 5; 12-2007; 804-8100731-7085CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/https://www.sciencedirect.com/science/article/abs/pii/S0731708507004384info:eu-repo/semantics/altIdentifier/doi/10.1016/j.jpba.2007.07.024info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-03T10:03:05Zoai:ri.conicet.gov.ar:11336/136552instacron: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 10:03:06.513CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Alternative and improved method for the simultaneous determination of fexofenadine and pseudoephedrine in their combined tablet formulation
title Alternative and improved method for the simultaneous determination of fexofenadine and pseudoephedrine in their combined tablet formulation
spellingShingle Alternative and improved method for the simultaneous determination of fexofenadine and pseudoephedrine in their combined tablet formulation
Maggio, Ruben Mariano
CHEMOMETRIC DETERMINATION
FEXOFENADINE HYDROCHLORIDE
IMPROVED METHOD
PSEUDOEPHEDRINE HYDROCHLORIDE
TABLETS
title_short Alternative and improved method for the simultaneous determination of fexofenadine and pseudoephedrine in their combined tablet formulation
title_full Alternative and improved method for the simultaneous determination of fexofenadine and pseudoephedrine in their combined tablet formulation
title_fullStr Alternative and improved method for the simultaneous determination of fexofenadine and pseudoephedrine in their combined tablet formulation
title_full_unstemmed Alternative and improved method for the simultaneous determination of fexofenadine and pseudoephedrine in their combined tablet formulation
title_sort Alternative and improved method for the simultaneous determination of fexofenadine and pseudoephedrine in their combined tablet formulation
dc.creator.none.fl_str_mv Maggio, Ruben Mariano
Castellano, Patricia Margarita
Vignaduzzo, Silvana Edit
Kaufman, Teodoro Saul
author Maggio, Ruben Mariano
author_facet Maggio, Ruben Mariano
Castellano, Patricia Margarita
Vignaduzzo, Silvana Edit
Kaufman, Teodoro Saul
author_role author
author2 Castellano, Patricia Margarita
Vignaduzzo, Silvana Edit
Kaufman, Teodoro Saul
author2_role author
author
author
dc.subject.none.fl_str_mv CHEMOMETRIC DETERMINATION
FEXOFENADINE HYDROCHLORIDE
IMPROVED METHOD
PSEUDOEPHEDRINE HYDROCHLORIDE
TABLETS
topic CHEMOMETRIC DETERMINATION
FEXOFENADINE HYDROCHLORIDE
IMPROVED METHOD
PSEUDOEPHEDRINE HYDROCHLORIDE
TABLETS
purl_subject.fl_str_mv https://purl.org/becyt/ford/1.4
https://purl.org/becyt/ford/1
dc.description.none.fl_txt_mv An alternative method for the determination of fexofenadine (FEX) and pseudoephedrine (PSE) in their combined tablet formulation has been developed, employing the partial least squares (PLS) analysis of spectral data of the analytes in their pharmaceutical association. A full-factorially designed set of 16 synthetic samples was employed for calibration purposes. The calibration models were constructed with wavelengths selection, in the ultraviolet region, according to their predictive ability. These were validated internally by the leave-one-out procedure and externally, employing appropriate sets of validation samples. The described method was linear for both analytes, over the range 160.6-301.2 mg L-1 for FEX (R2 = 0.9993) and between 325.6 and 610.5 mg L-1 for PSE (R2 = 0.9992). It was accurate, exhibiting 99.8% and 99.9% drug recoveries for FEX and PSE, respectively (N = 9), while in the intermediate precision experiment relative standard deviations were 1.4% for FEX and 1.2% for PSE. The contents of both analytes were assayed in commercial tablets employing this method and the results were compared with those furnished by HPLC, being in good statistical agreement. The method represents an improvement over the first derivative of spectral ratio (DSR) technique and allows high sample throughput with minimum reagent consumption and waste generation. The obtained results confirm that the method is highly suitable for its intended purpose.
Fil: Maggio, Ruben Mariano. 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: Vignaduzzo, Silvana Edit. 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 An alternative method for the determination of fexofenadine (FEX) and pseudoephedrine (PSE) in their combined tablet formulation has been developed, employing the partial least squares (PLS) analysis of spectral data of the analytes in their pharmaceutical association. A full-factorially designed set of 16 synthetic samples was employed for calibration purposes. The calibration models were constructed with wavelengths selection, in the ultraviolet region, according to their predictive ability. These were validated internally by the leave-one-out procedure and externally, employing appropriate sets of validation samples. The described method was linear for both analytes, over the range 160.6-301.2 mg L-1 for FEX (R2 = 0.9993) and between 325.6 and 610.5 mg L-1 for PSE (R2 = 0.9992). It was accurate, exhibiting 99.8% and 99.9% drug recoveries for FEX and PSE, respectively (N = 9), while in the intermediate precision experiment relative standard deviations were 1.4% for FEX and 1.2% for PSE. The contents of both analytes were assayed in commercial tablets employing this method and the results were compared with those furnished by HPLC, being in good statistical agreement. The method represents an improvement over the first derivative of spectral ratio (DSR) technique and allows high sample throughput with minimum reagent consumption and waste generation. The obtained results confirm that the method is highly suitable for its intended purpose.
publishDate 2007
dc.date.none.fl_str_mv 2007-12
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/11336/136552
Maggio, Ruben Mariano; Castellano, Patricia Margarita; Vignaduzzo, Silvana Edit; Kaufman, Teodoro Saul; Alternative and improved method for the simultaneous determination of fexofenadine and pseudoephedrine in their combined tablet formulation; Elsevier Science; Journal of Pharmaceutical and Biomedical Analysis; 45; 5; 12-2007; 804-810
0731-7085
CONICET Digital
CONICET
url http://hdl.handle.net/11336/136552
identifier_str_mv Maggio, Ruben Mariano; Castellano, Patricia Margarita; Vignaduzzo, Silvana Edit; Kaufman, Teodoro Saul; Alternative and improved method for the simultaneous determination of fexofenadine and pseudoephedrine in their combined tablet formulation; Elsevier Science; Journal of Pharmaceutical and Biomedical Analysis; 45; 5; 12-2007; 804-810
0731-7085
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.sciencedirect.com/science/article/abs/pii/S0731708507004384
info:eu-repo/semantics/altIdentifier/doi/10.1016/j.jpba.2007.07.024
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
application/pdf
application/pdf
dc.publisher.none.fl_str_mv Elsevier Science
publisher.none.fl_str_mv Elsevier Science
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 13.13397

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