Desenvolvimento e validação de metodologia analítica para avaliação de alisquireno em formulação farmacêutica
Autor(a) principal: | |
---|---|
Data de Publicação: | 2010 |
Tipo de documento: | Dissertação |
Idioma: | por |
Título da fonte: | Manancial - Repositório Digital da UFSM |
Texto Completo: | http://repositorio.ufsm.br/handle/1/5896 |
Resumo: | Aliskiren is the first representative of a new class of drugs, the low molecular weight renin inhibitors, orally active and clinically used in a new effective treatment for hypertension. In the present study, the methods were developed and validaded for assessment of aliskiren in pharmaceutical products. Aliskiren samples were also submitted to the physicochemical tests, meeting the specifications. The analysis by reversed-phase liquid chromatography were performed using Waters XBridge (150 mm x 4.6 mm i. d.), maintained at 25 °C. The mobile phase was consisted of acetonitrile/ water (95:5, v/v)/ 25 mM phosphoric acid pH 3.0 (40:60, v/v), run at flow rate of 1 mL/min and using UV detection at 229 nm. The chromatographic separation was obtained within 3.68 minutes. The spectrophotometric method was also developed and validaded, and the aliskiren can be quantified at 279 nm, using water as diluent. The procedures were validated evaluating parameters such as the specificity, linearity, precision, accuracy, limits of detection and quantitation, and robustness, giving results within the acceptable range. The proposed methods were applied for the analysis of pharmaceutical products, showing significant correlation (P > 0.05) of the results. The dissolution test was developed using 900 mL of 0.1 M of chloridric acid 37 ± 0.5 °C as dissolution medium, apparatus paddle at a stirring rate of 50 rpm and quantitation by spectrophotometric method. Therefore, the procedures can be applied to improve the quality control of pharmaceutical products and to assure the safety and therapeutic efficacy of the drug. |
id |
UFSM-20_697caaff734e625d4e5a2d5a03b34869 |
---|---|
oai_identifier_str |
oai:repositorio.ufsm.br:1/5896 |
network_acronym_str |
UFSM-20 |
network_name_str |
Manancial - Repositório Digital da UFSM |
repository_id_str |
3913 |
spelling |
2010-11-122010-11-122010-08-13SANGOI, Micheli Wrasse. Development and validation of analytical methodology for the evaluation of aliskiren in pharmaceutical formulation. 2010. 78 f. Dissertação (Mestrado em Farmacologia) - Universidade Federal de Santa Maria, Santa Maria, 2010.http://repositorio.ufsm.br/handle/1/5896Aliskiren is the first representative of a new class of drugs, the low molecular weight renin inhibitors, orally active and clinically used in a new effective treatment for hypertension. In the present study, the methods were developed and validaded for assessment of aliskiren in pharmaceutical products. Aliskiren samples were also submitted to the physicochemical tests, meeting the specifications. The analysis by reversed-phase liquid chromatography were performed using Waters XBridge (150 mm x 4.6 mm i. d.), maintained at 25 °C. The mobile phase was consisted of acetonitrile/ water (95:5, v/v)/ 25 mM phosphoric acid pH 3.0 (40:60, v/v), run at flow rate of 1 mL/min and using UV detection at 229 nm. The chromatographic separation was obtained within 3.68 minutes. The spectrophotometric method was also developed and validaded, and the aliskiren can be quantified at 279 nm, using water as diluent. The procedures were validated evaluating parameters such as the specificity, linearity, precision, accuracy, limits of detection and quantitation, and robustness, giving results within the acceptable range. The proposed methods were applied for the analysis of pharmaceutical products, showing significant correlation (P > 0.05) of the results. The dissolution test was developed using 900 mL of 0.1 M of chloridric acid 37 ± 0.5 °C as dissolution medium, apparatus paddle at a stirring rate of 50 rpm and quantitation by spectrophotometric method. Therefore, the procedures can be applied to improve the quality control of pharmaceutical products and to assure the safety and therapeutic efficacy of the drug.O alisquireno é o primeiro representante de uma nova classe de inibidores da renina, de baixo peso molecular e ativo por via oral, sendo utilizado clinicamente em um novo e eficaz tratamento para a hipertensão arterial (HA). No presente trabalho, foram desenvolvidos e validados métodos para avaliação de alisquireno em produtos farmacêuticos. Submeteram-se os produtos aos testes físico-químicos, mostrando que cumprem as especificações. As análises por cromatografia líquida em fase reversa foram realizadas utilizando coluna Waters XBridge (150 mm x 4,6 mm d. i.), mantida à 25 ºC. A fase móvel foi composta de acetonitrila/ água (95:5, v/v)/ ácido fosfórico 25 mM pH 3,0 (40:60, v/v), eluída na vazão de 1 mL/min e detecção no ultravioleta a 229 nm. A separação cromatográfica foi obtida no tempo de 3,68 minutos. Paralelamente, desenvolveu-se e validou-se método por espectrofotometria no ultravioleta (UV) em 279 nm, utilizando água como diluente. Os procedimentos foram validados, avaliando-se os parâmetros de especificidade, linearidade, precisão, exatidão, robustez e limite de detecção e quantificação, cujos resultados cumpriram os requisitos preconizados. Os métodos propostos foram aplicados na análise de produtos farmacêuticos, demonstrando correlação significativa dos resultados (P > 0,05). Desenvolveu-se método de dissolução do fármaco, utilizando como meio 900 mL de ácido clorídrico 0,1 M mantido a 37 ± 0,5 °C, aparato pá, rotação de 50 rpm e quantificação por espectrofotometria no UV. Desse modo, estabeleceram-se procedimentos que podem ser aplicados para aprimorar o controle da qualidade de medicamentos, bem como contribuir para garantir a segurança e eficácia no uso terapêutico.application/pdfporUniversidade Federal de Santa MariaPrograma de Pós-Graduação em Ciências FarmacêuticasUFSMBRFarmáciaAlisquirenoCromatografia líquidaEspectrofotometriaValidaçãoDissoluçãoAliskirenLiquid chromatographySpectrophotometryValidationDissolutionCNPQ::CIENCIAS DA SAUDE::FARMACIADesenvolvimento e validação de metodologia analítica para avaliação de alisquireno em formulação farmacêuticaDevelopment and validation of analytical methodology for the evaluation of aliskiren in pharmaceutical formulationinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/masterThesisRolim, Clarice Madalena Buenohttp://lattes.cnpq.br/2270654658839508Donato, Eliane Mariahttp://lattes.cnpq.br/6369725960014899Dalmora, Sergio Luizhttp://lattes.cnpq.br/4505166045049607http://lattes.cnpq.br/4678189142359177Sangoi, Micheli Wrasse201000000000400300300300300dced70fb-2e68-45f2-9d89-dc395bc6c034dcdc845c-40d3-4e19-95b6-7e6f06bc7b6108305957-85c4-44cf-b850-c4e7d5c3ddfa21cb691b-69dd-4b51-a4ce-c0e6d97d3f2einfo:eu-repo/semantics/openAccessreponame:Manancial - Repositório Digital da UFSMinstname:Universidade Federal de Santa Maria (UFSM)instacron:UFSMORIGINALSANGOI, MICHELI WRASSE.pdfapplication/pdf954565http://repositorio.ufsm.br/bitstream/1/5896/1/SANGOI%2c%20MICHELI%20WRASSE.pdf067e23b1616a247fc1b3f932aa5f7d61MD51TEXTSANGOI, MICHELI WRASSE.pdf.txtSANGOI, MICHELI WRASSE.pdf.txtExtracted texttext/plain145951http://repositorio.ufsm.br/bitstream/1/5896/2/SANGOI%2c%20MICHELI%20WRASSE.pdf.txtad9d0dda948d3864e8964043eae90f4bMD52THUMBNAILSANGOI, MICHELI WRASSE.pdf.jpgSANGOI, MICHELI WRASSE.pdf.jpgIM Thumbnailimage/jpeg2795http://repositorio.ufsm.br/bitstream/1/5896/3/SANGOI%2c%20MICHELI%20WRASSE.pdf.jpgeae007621c8771396d711b6a740cde4dMD531/58962022-10-19 13:38:23.96oai:repositorio.ufsm.br:1/5896Repositório Institucionalhttp://repositorio.ufsm.br/PUBhttp://repositorio.ufsm.br/oai/requestopendoar:39132022-10-19T16:38:23Manancial - Repositório Digital da UFSM - Universidade Federal de Santa Maria (UFSM)false |
dc.title.por.fl_str_mv |
Desenvolvimento e validação de metodologia analítica para avaliação de alisquireno em formulação farmacêutica |
dc.title.alternative.eng.fl_str_mv |
Development and validation of analytical methodology for the evaluation of aliskiren in pharmaceutical formulation |
title |
Desenvolvimento e validação de metodologia analítica para avaliação de alisquireno em formulação farmacêutica |
spellingShingle |
Desenvolvimento e validação de metodologia analítica para avaliação de alisquireno em formulação farmacêutica Sangoi, Micheli Wrasse Alisquireno Cromatografia líquida Espectrofotometria Validação Dissolução Aliskiren Liquid chromatography Spectrophotometry Validation Dissolution CNPQ::CIENCIAS DA SAUDE::FARMACIA |
title_short |
Desenvolvimento e validação de metodologia analítica para avaliação de alisquireno em formulação farmacêutica |
title_full |
Desenvolvimento e validação de metodologia analítica para avaliação de alisquireno em formulação farmacêutica |
title_fullStr |
Desenvolvimento e validação de metodologia analítica para avaliação de alisquireno em formulação farmacêutica |
title_full_unstemmed |
Desenvolvimento e validação de metodologia analítica para avaliação de alisquireno em formulação farmacêutica |
title_sort |
Desenvolvimento e validação de metodologia analítica para avaliação de alisquireno em formulação farmacêutica |
author |
Sangoi, Micheli Wrasse |
author_facet |
Sangoi, Micheli Wrasse |
author_role |
author |
dc.contributor.advisor1.fl_str_mv |
Rolim, Clarice Madalena Bueno |
dc.contributor.advisor1Lattes.fl_str_mv |
http://lattes.cnpq.br/2270654658839508 |
dc.contributor.referee1.fl_str_mv |
Donato, Eliane Maria |
dc.contributor.referee1Lattes.fl_str_mv |
http://lattes.cnpq.br/6369725960014899 |
dc.contributor.referee2.fl_str_mv |
Dalmora, Sergio Luiz |
dc.contributor.referee2Lattes.fl_str_mv |
http://lattes.cnpq.br/4505166045049607 |
dc.contributor.authorLattes.fl_str_mv |
http://lattes.cnpq.br/4678189142359177 |
dc.contributor.author.fl_str_mv |
Sangoi, Micheli Wrasse |
contributor_str_mv |
Rolim, Clarice Madalena Bueno Donato, Eliane Maria Dalmora, Sergio Luiz |
dc.subject.por.fl_str_mv |
Alisquireno Cromatografia líquida Espectrofotometria Validação Dissolução |
topic |
Alisquireno Cromatografia líquida Espectrofotometria Validação Dissolução Aliskiren Liquid chromatography Spectrophotometry Validation Dissolution CNPQ::CIENCIAS DA SAUDE::FARMACIA |
dc.subject.eng.fl_str_mv |
Aliskiren Liquid chromatography Spectrophotometry Validation Dissolution |
dc.subject.cnpq.fl_str_mv |
CNPQ::CIENCIAS DA SAUDE::FARMACIA |
description |
Aliskiren is the first representative of a new class of drugs, the low molecular weight renin inhibitors, orally active and clinically used in a new effective treatment for hypertension. In the present study, the methods were developed and validaded for assessment of aliskiren in pharmaceutical products. Aliskiren samples were also submitted to the physicochemical tests, meeting the specifications. The analysis by reversed-phase liquid chromatography were performed using Waters XBridge (150 mm x 4.6 mm i. d.), maintained at 25 °C. The mobile phase was consisted of acetonitrile/ water (95:5, v/v)/ 25 mM phosphoric acid pH 3.0 (40:60, v/v), run at flow rate of 1 mL/min and using UV detection at 229 nm. The chromatographic separation was obtained within 3.68 minutes. The spectrophotometric method was also developed and validaded, and the aliskiren can be quantified at 279 nm, using water as diluent. The procedures were validated evaluating parameters such as the specificity, linearity, precision, accuracy, limits of detection and quantitation, and robustness, giving results within the acceptable range. The proposed methods were applied for the analysis of pharmaceutical products, showing significant correlation (P > 0.05) of the results. The dissolution test was developed using 900 mL of 0.1 M of chloridric acid 37 ± 0.5 °C as dissolution medium, apparatus paddle at a stirring rate of 50 rpm and quantitation by spectrophotometric method. Therefore, the procedures can be applied to improve the quality control of pharmaceutical products and to assure the safety and therapeutic efficacy of the drug. |
publishDate |
2010 |
dc.date.accessioned.fl_str_mv |
2010-11-12 |
dc.date.available.fl_str_mv |
2010-11-12 |
dc.date.issued.fl_str_mv |
2010-08-13 |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/masterThesis |
format |
masterThesis |
status_str |
publishedVersion |
dc.identifier.citation.fl_str_mv |
SANGOI, Micheli Wrasse. Development and validation of analytical methodology for the evaluation of aliskiren in pharmaceutical formulation. 2010. 78 f. Dissertação (Mestrado em Farmacologia) - Universidade Federal de Santa Maria, Santa Maria, 2010. |
dc.identifier.uri.fl_str_mv |
http://repositorio.ufsm.br/handle/1/5896 |
identifier_str_mv |
SANGOI, Micheli Wrasse. Development and validation of analytical methodology for the evaluation of aliskiren in pharmaceutical formulation. 2010. 78 f. Dissertação (Mestrado em Farmacologia) - Universidade Federal de Santa Maria, Santa Maria, 2010. |
url |
http://repositorio.ufsm.br/handle/1/5896 |
dc.language.iso.fl_str_mv |
por |
language |
por |
dc.relation.cnpq.fl_str_mv |
201000000000 |
dc.relation.confidence.fl_str_mv |
400 300 300 300 300 |
dc.relation.authority.fl_str_mv |
dced70fb-2e68-45f2-9d89-dc395bc6c034 dcdc845c-40d3-4e19-95b6-7e6f06bc7b61 08305957-85c4-44cf-b850-c4e7d5c3ddfa 21cb691b-69dd-4b51-a4ce-c0e6d97d3f2e |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf |
dc.publisher.none.fl_str_mv |
Universidade Federal de Santa Maria |
dc.publisher.program.fl_str_mv |
Programa de Pós-Graduação em Ciências Farmacêuticas |
dc.publisher.initials.fl_str_mv |
UFSM |
dc.publisher.country.fl_str_mv |
BR |
dc.publisher.department.fl_str_mv |
Farmácia |
publisher.none.fl_str_mv |
Universidade Federal de Santa Maria |
dc.source.none.fl_str_mv |
reponame:Manancial - Repositório Digital da UFSM instname:Universidade Federal de Santa Maria (UFSM) instacron:UFSM |
instname_str |
Universidade Federal de Santa Maria (UFSM) |
instacron_str |
UFSM |
institution |
UFSM |
reponame_str |
Manancial - Repositório Digital da UFSM |
collection |
Manancial - Repositório Digital da UFSM |
bitstream.url.fl_str_mv |
http://repositorio.ufsm.br/bitstream/1/5896/1/SANGOI%2c%20MICHELI%20WRASSE.pdf http://repositorio.ufsm.br/bitstream/1/5896/2/SANGOI%2c%20MICHELI%20WRASSE.pdf.txt http://repositorio.ufsm.br/bitstream/1/5896/3/SANGOI%2c%20MICHELI%20WRASSE.pdf.jpg |
bitstream.checksum.fl_str_mv |
067e23b1616a247fc1b3f932aa5f7d61 ad9d0dda948d3864e8964043eae90f4b eae007621c8771396d711b6a740cde4d |
bitstream.checksumAlgorithm.fl_str_mv |
MD5 MD5 MD5 |
repository.name.fl_str_mv |
Manancial - Repositório Digital da UFSM - Universidade Federal de Santa Maria (UFSM) |
repository.mail.fl_str_mv |
|
_version_ |
1801223785108471808 |