Multivariate optimization and validation of an analytical methodology by RP-HPLC for the determination of losartan potassium in capsules
Autor(a) principal: | |
---|---|
Data de Publicação: | 2009 |
Outros Autores: | , , , |
Tipo de documento: | Artigo de conferência |
Idioma: | eng |
Título da fonte: | Repositório Institucional da UNESP |
Texto Completo: | http://dx.doi.org/10.1016/j.talanta.2009.06.060 http://hdl.handle.net/11449/7835 |
Resumo: | This paper describes the optimization and validation of an analytical methodology for the determination of losartan potassium in capsules by HPLC using 2(5-1) fractional factorial and Doehlert designs. This multivariate approach allows a considerable improvement in chromatographic performance using fewer experiments, without additional cost for columns or other equipment. The HPLC method utilized potassium phosphate buffer (pH 6.2: 58 mmol L(-1))-acetonitrile (65:35, v/v) as the mobile phase, pumped at a flow rate of 1.0 mL min(-1). An octylsilane column (100 mm x 4.6 mm W., 5 mu m) maintained at 35 degrees C was used as the stationary phase. UV detection was performed at 254 nm. The method was validated according to the ICH guidelines, showing accuracy, precision (intra-day relative standard deviation (R.S.D.) and inter-day R.S.D values <2.0%). selectivity, robustness and linearity (r=0.9998) over a concentration range from 30 to 70 mg L(-1) of losartan potassium. The limits of detection and quantification were 0.114 and 0.420 mg L(-1), respectively. The validated method may be used to quantify losartan potassium in capsules and to determine the stability of this drug. (C) 2009 Elsevier B.V. All rights reserved. |
id |
UNSP_2ff90025918e7b20f01272269aa24867 |
---|---|
oai_identifier_str |
oai:repositorio.unesp.br:11449/7835 |
network_acronym_str |
UNSP |
network_name_str |
Repositório Institucional da UNESP |
repository_id_str |
2946 |
spelling |
Multivariate optimization and validation of an analytical methodology by RP-HPLC for the determination of losartan potassium in capsulesDoehlert designFractional factorial designLosartan potassiumReversed-phase chromatographyValidationThis paper describes the optimization and validation of an analytical methodology for the determination of losartan potassium in capsules by HPLC using 2(5-1) fractional factorial and Doehlert designs. This multivariate approach allows a considerable improvement in chromatographic performance using fewer experiments, without additional cost for columns or other equipment. The HPLC method utilized potassium phosphate buffer (pH 6.2: 58 mmol L(-1))-acetonitrile (65:35, v/v) as the mobile phase, pumped at a flow rate of 1.0 mL min(-1). An octylsilane column (100 mm x 4.6 mm W., 5 mu m) maintained at 35 degrees C was used as the stationary phase. UV detection was performed at 254 nm. The method was validated according to the ICH guidelines, showing accuracy, precision (intra-day relative standard deviation (R.S.D.) and inter-day R.S.D values <2.0%). selectivity, robustness and linearity (r=0.9998) over a concentration range from 30 to 70 mg L(-1) of losartan potassium. The limits of detection and quantification were 0.114 and 0.420 mg L(-1), respectively. The validated method may be used to quantify losartan potassium in capsules and to determine the stability of this drug. (C) 2009 Elsevier B.V. All rights reserved.Center of Pharmaceutical Equivalence of the Federal University of AlfenasFederal University of AlfenasConselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)Univ Fed Alfenas, Dept Farm, BR-37130000 Alfenas, MG, BrazilUniv Fed Alfenas, Dept Ciencias Exatas, BR-37130000 Alfenas, MG, BrazilUniv Estadual Paulista, Fac Ciencias Farmaceut, Dept Farm & Medicamentos, BR-14801902 Araraquara, SP, BrazilUniv Estadual Campinas, UNICAMP, Inst Quim, Inst Nacl Ciência & Tecnol Bioanalit,Dept Quim An, BR-13083970 Campinas, SP, BrazilUniv Estadual Paulista, Fac Ciencias Farmaceut, Dept Farm & Medicamentos, BR-14801902 Araraquara, SP, BrazilElsevier B.V.Universidade Federal de Alfenas (UNIFAL)Universidade Estadual Paulista (Unesp)Universidade Estadual de Campinas (UNICAMP)Bonfilio, RudyTeixeira Tarley, Cesar RicardoPereira, Gislaine RibeiroSalgado, Hérida Regina Nunes [UNESP]de Araujo, Magali Benjamim2014-05-20T13:24:52Z2014-05-20T13:24:52Z2009-11-15info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/conferenceObject236-241http://dx.doi.org/10.1016/j.talanta.2009.06.060Talanta. Amsterdam: Elsevier B.V., v. 80, n. 1, p. 236-241, 2009.0039-9140http://hdl.handle.net/11449/783510.1016/j.talanta.2009.06.060WOS:000271055700036Web of Sciencereponame:Repositório Institucional da UNESPinstname:Universidade Estadual Paulista (UNESP)instacron:UNESPengTalanta4.2441,186info:eu-repo/semantics/openAccess2024-06-24T13:47:04Zoai:repositorio.unesp.br:11449/7835Repositório InstitucionalPUBhttp://repositorio.unesp.br/oai/requestopendoar:29462024-06-24T13:47:04Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)false |
dc.title.none.fl_str_mv |
Multivariate optimization and validation of an analytical methodology by RP-HPLC for the determination of losartan potassium in capsules |
title |
Multivariate optimization and validation of an analytical methodology by RP-HPLC for the determination of losartan potassium in capsules |
spellingShingle |
Multivariate optimization and validation of an analytical methodology by RP-HPLC for the determination of losartan potassium in capsules Bonfilio, Rudy Doehlert design Fractional factorial design Losartan potassium Reversed-phase chromatography Validation |
title_short |
Multivariate optimization and validation of an analytical methodology by RP-HPLC for the determination of losartan potassium in capsules |
title_full |
Multivariate optimization and validation of an analytical methodology by RP-HPLC for the determination of losartan potassium in capsules |
title_fullStr |
Multivariate optimization and validation of an analytical methodology by RP-HPLC for the determination of losartan potassium in capsules |
title_full_unstemmed |
Multivariate optimization and validation of an analytical methodology by RP-HPLC for the determination of losartan potassium in capsules |
title_sort |
Multivariate optimization and validation of an analytical methodology by RP-HPLC for the determination of losartan potassium in capsules |
author |
Bonfilio, Rudy |
author_facet |
Bonfilio, Rudy Teixeira Tarley, Cesar Ricardo Pereira, Gislaine Ribeiro Salgado, Hérida Regina Nunes [UNESP] de Araujo, Magali Benjamim |
author_role |
author |
author2 |
Teixeira Tarley, Cesar Ricardo Pereira, Gislaine Ribeiro Salgado, Hérida Regina Nunes [UNESP] de Araujo, Magali Benjamim |
author2_role |
author author author author |
dc.contributor.none.fl_str_mv |
Universidade Federal de Alfenas (UNIFAL) Universidade Estadual Paulista (Unesp) Universidade Estadual de Campinas (UNICAMP) |
dc.contributor.author.fl_str_mv |
Bonfilio, Rudy Teixeira Tarley, Cesar Ricardo Pereira, Gislaine Ribeiro Salgado, Hérida Regina Nunes [UNESP] de Araujo, Magali Benjamim |
dc.subject.por.fl_str_mv |
Doehlert design Fractional factorial design Losartan potassium Reversed-phase chromatography Validation |
topic |
Doehlert design Fractional factorial design Losartan potassium Reversed-phase chromatography Validation |
description |
This paper describes the optimization and validation of an analytical methodology for the determination of losartan potassium in capsules by HPLC using 2(5-1) fractional factorial and Doehlert designs. This multivariate approach allows a considerable improvement in chromatographic performance using fewer experiments, without additional cost for columns or other equipment. The HPLC method utilized potassium phosphate buffer (pH 6.2: 58 mmol L(-1))-acetonitrile (65:35, v/v) as the mobile phase, pumped at a flow rate of 1.0 mL min(-1). An octylsilane column (100 mm x 4.6 mm W., 5 mu m) maintained at 35 degrees C was used as the stationary phase. UV detection was performed at 254 nm. The method was validated according to the ICH guidelines, showing accuracy, precision (intra-day relative standard deviation (R.S.D.) and inter-day R.S.D values <2.0%). selectivity, robustness and linearity (r=0.9998) over a concentration range from 30 to 70 mg L(-1) of losartan potassium. The limits of detection and quantification were 0.114 and 0.420 mg L(-1), respectively. The validated method may be used to quantify losartan potassium in capsules and to determine the stability of this drug. (C) 2009 Elsevier B.V. All rights reserved. |
publishDate |
2009 |
dc.date.none.fl_str_mv |
2009-11-15 2014-05-20T13:24:52Z 2014-05-20T13:24:52Z |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/conferenceObject |
format |
conferenceObject |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://dx.doi.org/10.1016/j.talanta.2009.06.060 Talanta. Amsterdam: Elsevier B.V., v. 80, n. 1, p. 236-241, 2009. 0039-9140 http://hdl.handle.net/11449/7835 10.1016/j.talanta.2009.06.060 WOS:000271055700036 |
url |
http://dx.doi.org/10.1016/j.talanta.2009.06.060 http://hdl.handle.net/11449/7835 |
identifier_str_mv |
Talanta. Amsterdam: Elsevier B.V., v. 80, n. 1, p. 236-241, 2009. 0039-9140 10.1016/j.talanta.2009.06.060 WOS:000271055700036 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
Talanta 4.244 1,186 |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
236-241 |
dc.publisher.none.fl_str_mv |
Elsevier B.V. |
publisher.none.fl_str_mv |
Elsevier B.V. |
dc.source.none.fl_str_mv |
Web of Science reponame:Repositório Institucional da UNESP instname:Universidade Estadual Paulista (UNESP) instacron:UNESP |
instname_str |
Universidade Estadual Paulista (UNESP) |
instacron_str |
UNESP |
institution |
UNESP |
reponame_str |
Repositório Institucional da UNESP |
collection |
Repositório Institucional da UNESP |
repository.name.fl_str_mv |
Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP) |
repository.mail.fl_str_mv |
|
_version_ |
1803045436087336960 |