Obtenção e caracterização química e farmacocinética do produto de fotodegradação do nifedipino
Autor(a) principal: | |
---|---|
Data de Publicação: | 2013 |
Tipo de documento: | Tese |
Idioma: | por |
Título da fonte: | Repositório Institucional da UFG |
dARK ID: | ark:/38995/0013000000gzm |
Texto Completo: | http://repositorio.bc.ufg.br/tede/handle/tede/8672 |
Resumo: | A simple and accurate stability-indicating high-performance liquid chromatography (HPLC-DAD) method was developed to measure nifedipine (NIF) in plasma in the presence of its degradation products. The chromatographic separation was performed on a C18 column using H3PO4 0.01%:CH3CN:CH3OH (60:20:20, v/v/v) as the mobile phase and a 1.0ml/min flow rate. The analytical validation was performed according to FDA, EMA and ANVISA (Brazilian Health Surveillance Agency) guidelines and was linear between 100.0 and 2000.0 ng/ml, precise (1.9 to 11.3%) and accurate (86.0 to 113.1%). Under the evaluated conditions, NIF in plasma samples were stable after processing and freeze-thaw cycles. The average liquid-liquid extraction recovery was 101.3 ± 5.4%. After validation, this method was applied to evaluate the influence of nitrosophenylpyridine (NO-NIF) in the pharmacokinetic of NIF in plasma of Wistar rats. This method was also validated for quality control of NO-NIF obtained after photodegradation of NIF in photostability chamber. The method showed selectivity, linearity (0.4 to 2.4mg/ml), as well as precision and accuracy. Nitrophenylpyridine (NINIF) was synthesized from the NIF. These degradation products were characterized by NMR and mass spectroscopy. In addition, a breakdown product of NO-NIF due to its contact with plasma was identified and characterized. |
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Rezende, Kênnia Rochahttp://buscatextual.cnpq.br/buscatextual/visualizacv.do?id=K4796510P9Rezende, Kênnia RochaCarvalho, Rosângela de Oliveira AlvesSantos, Pierre Alexandre dosLião, Luciano MoraisMenegatti, Ricardohttp://buscatextual.cnpq.br/buscatextual/visualizacv.do?id=K4259381A9Oliveira, Maysa Aparecida de2018-07-10T11:10:17Z2013-07-16OLIVEIRA, Maysa Aparecida de. Obtenção e caracterização química e farmacocinética do produto de fotodegradação do nifedipino. 2013. 93 f. Tese (Doutorado em Ciências da Saúde) - Universidade Federal de Goiás, Goiânia, 2013.http://repositorio.bc.ufg.br/tede/handle/tede/8672ark:/38995/0013000000gzmA simple and accurate stability-indicating high-performance liquid chromatography (HPLC-DAD) method was developed to measure nifedipine (NIF) in plasma in the presence of its degradation products. The chromatographic separation was performed on a C18 column using H3PO4 0.01%:CH3CN:CH3OH (60:20:20, v/v/v) as the mobile phase and a 1.0ml/min flow rate. The analytical validation was performed according to FDA, EMA and ANVISA (Brazilian Health Surveillance Agency) guidelines and was linear between 100.0 and 2000.0 ng/ml, precise (1.9 to 11.3%) and accurate (86.0 to 113.1%). Under the evaluated conditions, NIF in plasma samples were stable after processing and freeze-thaw cycles. The average liquid-liquid extraction recovery was 101.3 ± 5.4%. After validation, this method was applied to evaluate the influence of nitrosophenylpyridine (NO-NIF) in the pharmacokinetic of NIF in plasma of Wistar rats. This method was also validated for quality control of NO-NIF obtained after photodegradation of NIF in photostability chamber. The method showed selectivity, linearity (0.4 to 2.4mg/ml), as well as precision and accuracy. Nitrophenylpyridine (NINIF) was synthesized from the NIF. These degradation products were characterized by NMR and mass spectroscopy. In addition, a breakdown product of NO-NIF due to its contact with plasma was identified and characterized.Um método simples, rápido e preciso por cromatografia líquida de alta eficiência (HPLC-DAD) foi desenvolvido para determinação de nifedipino (NIF) na presença de seus produtos de degradação em amostras de plasma. A separação cromatográfica foi realizada em coluna C18 empregando H3PO4 0,01%:CH3CN:CH3OH (60:20:20 v/v/v) como fase móvel e vazão de 1,0mL/min. A validação procedeu-se segundo as recomendações dos guias editados pela ANVISA, EMA e FDA e apresentou linearidade no intervalo de 100,0 a 2000,0ng/mL com precisão (1,9 a 11,3%) e exatidão 86,0 a 113,1%) adequadas. Nas condições avaliadas, as amostras de NIF mostraram-se estáveis tanto em plasma como após processamento e ciclos de congelamento e descongelamento. A eficiência do método de extração líquido-líquido demonstrou recuperação média de 101,3 ± 5,4%. Após a etapa de validação, o método foi aplicado em estudos farmacocinéticos para avaliação da influência do nitrosofenilpiridino (NO-NIF) na farmacocinética do NIF. Este método também foi validado para o controle de qualidade do NO-NIF obtido após fotodegradação do NIF em câmara de fotoestabilidade e apresentou seletividade, linearidade (0,4 a 2,4μg/mL), assim como precisão e exatidão. Além da obtenção do NO-NIF por fotodegradação, nitrofenilpiridino (NI-NIF) foi sintetizado a partir do NIF. Esses produtos de degradação foram caracterizados por RMN e espectrometria de massas. Além disso, um produto de degradação do NO-NIF decorrente do seu contato com plasma foi identificado e caracterizado.Submitted by Marlene Santos (marlene.bc.ufg@gmail.com) on 2018-07-09T16:12:59Z No. of bitstreams: 2 Tese- Maysa Aparecida de Oliveira - 2013.pdf: 2303389 bytes, checksum: d6b1b0186001f327c5e50809b8d401fb (MD5) license_rdf: 0 bytes, checksum: d41d8cd98f00b204e9800998ecf8427e (MD5)Approved for entry into archive by Luciana Ferreira (lucgeral@gmail.com) on 2018-07-10T11:10:17Z (GMT) No. of bitstreams: 2 Tese- Maysa Aparecida de Oliveira - 2013.pdf: 2303389 bytes, checksum: d6b1b0186001f327c5e50809b8d401fb (MD5) license_rdf: 0 bytes, checksum: d41d8cd98f00b204e9800998ecf8427e (MD5)Made available in DSpace on 2018-07-10T11:10:17Z (GMT). No. of bitstreams: 2 Tese- Maysa Aparecida de Oliveira - 2013.pdf: 2303389 bytes, checksum: d6b1b0186001f327c5e50809b8d401fb (MD5) license_rdf: 0 bytes, checksum: d41d8cd98f00b204e9800998ecf8427e (MD5) Previous issue date: 2013-07-16application/pdfporUniversidade Federal de GoiásPrograma de Pós-graduação em Ciências da Saúde (FM)UFGBrasilFaculdade de Medicina - FM (RG)http://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessMétodo bioanalíticoHPLC-DADNifedipinoFarmacocinéticaValidaçãoBioanalytical methodNifedipinePharmacokineticsValidationCIENCIAS DA SAUDE::MEDICINAObtenção e caracterização química e farmacocinética do produto de fotodegradação do nifedipinoObtaining and chemical characterization of nifedipineinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/doctoralThesis-10068643126177453106006006001545772475950486338-969369452308786627reponame:Repositório Institucional da UFGinstname:Universidade Federal de Goiás (UFG)instacron:UFGORIGINALTese - Maysa Aparecida de Oliveira - 2013.pdfTese - Maysa Aparecida de Oliveira - 2013.pdfapplication/pdf2303389http://repositorio.bc.ufg.br/tede/bitstreams/b174bd0e-1bbe-4948-af42-c12d9191045a/downloadd6b1b0186001f327c5e50809b8d401fbMD55LICENSElicense.txtlicense.txttext/plain; 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dc.title.eng.fl_str_mv |
Obtenção e caracterização química e farmacocinética do produto de fotodegradação do nifedipino |
dc.title.alternative.eng.fl_str_mv |
Obtaining and chemical characterization of nifedipine |
title |
Obtenção e caracterização química e farmacocinética do produto de fotodegradação do nifedipino |
spellingShingle |
Obtenção e caracterização química e farmacocinética do produto de fotodegradação do nifedipino Oliveira, Maysa Aparecida de Método bioanalítico HPLC-DAD Nifedipino Farmacocinética Validação Bioanalytical method Nifedipine Pharmacokinetics Validation CIENCIAS DA SAUDE::MEDICINA |
title_short |
Obtenção e caracterização química e farmacocinética do produto de fotodegradação do nifedipino |
title_full |
Obtenção e caracterização química e farmacocinética do produto de fotodegradação do nifedipino |
title_fullStr |
Obtenção e caracterização química e farmacocinética do produto de fotodegradação do nifedipino |
title_full_unstemmed |
Obtenção e caracterização química e farmacocinética do produto de fotodegradação do nifedipino |
title_sort |
Obtenção e caracterização química e farmacocinética do produto de fotodegradação do nifedipino |
author |
Oliveira, Maysa Aparecida de |
author_facet |
Oliveira, Maysa Aparecida de |
author_role |
author |
dc.contributor.advisor1.fl_str_mv |
Rezende, Kênnia Rocha |
dc.contributor.advisor1Lattes.fl_str_mv |
http://buscatextual.cnpq.br/buscatextual/visualizacv.do?id=K4796510P9 |
dc.contributor.referee1.fl_str_mv |
Rezende, Kênnia Rocha |
dc.contributor.referee2.fl_str_mv |
Carvalho, Rosângela de Oliveira Alves |
dc.contributor.referee3.fl_str_mv |
Santos, Pierre Alexandre dos |
dc.contributor.referee4.fl_str_mv |
Lião, Luciano Morais |
dc.contributor.referee5.fl_str_mv |
Menegatti, Ricardo |
dc.contributor.authorLattes.fl_str_mv |
http://buscatextual.cnpq.br/buscatextual/visualizacv.do?id=K4259381A9 |
dc.contributor.author.fl_str_mv |
Oliveira, Maysa Aparecida de |
contributor_str_mv |
Rezende, Kênnia Rocha Rezende, Kênnia Rocha Carvalho, Rosângela de Oliveira Alves Santos, Pierre Alexandre dos Lião, Luciano Morais Menegatti, Ricardo |
dc.subject.por.fl_str_mv |
Método bioanalítico HPLC-DAD Nifedipino Farmacocinética Validação |
topic |
Método bioanalítico HPLC-DAD Nifedipino Farmacocinética Validação Bioanalytical method Nifedipine Pharmacokinetics Validation CIENCIAS DA SAUDE::MEDICINA |
dc.subject.eng.fl_str_mv |
Bioanalytical method Nifedipine Pharmacokinetics Validation |
dc.subject.cnpq.fl_str_mv |
CIENCIAS DA SAUDE::MEDICINA |
description |
A simple and accurate stability-indicating high-performance liquid chromatography (HPLC-DAD) method was developed to measure nifedipine (NIF) in plasma in the presence of its degradation products. The chromatographic separation was performed on a C18 column using H3PO4 0.01%:CH3CN:CH3OH (60:20:20, v/v/v) as the mobile phase and a 1.0ml/min flow rate. The analytical validation was performed according to FDA, EMA and ANVISA (Brazilian Health Surveillance Agency) guidelines and was linear between 100.0 and 2000.0 ng/ml, precise (1.9 to 11.3%) and accurate (86.0 to 113.1%). Under the evaluated conditions, NIF in plasma samples were stable after processing and freeze-thaw cycles. The average liquid-liquid extraction recovery was 101.3 ± 5.4%. After validation, this method was applied to evaluate the influence of nitrosophenylpyridine (NO-NIF) in the pharmacokinetic of NIF in plasma of Wistar rats. This method was also validated for quality control of NO-NIF obtained after photodegradation of NIF in photostability chamber. The method showed selectivity, linearity (0.4 to 2.4mg/ml), as well as precision and accuracy. Nitrophenylpyridine (NINIF) was synthesized from the NIF. These degradation products were characterized by NMR and mass spectroscopy. In addition, a breakdown product of NO-NIF due to its contact with plasma was identified and characterized. |
publishDate |
2013 |
dc.date.issued.fl_str_mv |
2013-07-16 |
dc.date.accessioned.fl_str_mv |
2018-07-10T11:10:17Z |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/doctoralThesis |
format |
doctoralThesis |
status_str |
publishedVersion |
dc.identifier.citation.fl_str_mv |
OLIVEIRA, Maysa Aparecida de. Obtenção e caracterização química e farmacocinética do produto de fotodegradação do nifedipino. 2013. 93 f. Tese (Doutorado em Ciências da Saúde) - Universidade Federal de Goiás, Goiânia, 2013. |
dc.identifier.uri.fl_str_mv |
http://repositorio.bc.ufg.br/tede/handle/tede/8672 |
dc.identifier.dark.fl_str_mv |
ark:/38995/0013000000gzm |
identifier_str_mv |
OLIVEIRA, Maysa Aparecida de. Obtenção e caracterização química e farmacocinética do produto de fotodegradação do nifedipino. 2013. 93 f. Tese (Doutorado em Ciências da Saúde) - Universidade Federal de Goiás, Goiânia, 2013. ark:/38995/0013000000gzm |
url |
http://repositorio.bc.ufg.br/tede/handle/tede/8672 |
dc.language.iso.fl_str_mv |
por |
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por |
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dc.relation.confidence.fl_str_mv |
600 600 600 |
dc.relation.department.fl_str_mv |
1545772475950486338 |
dc.relation.cnpq.fl_str_mv |
-969369452308786627 |
dc.rights.driver.fl_str_mv |
http://creativecommons.org/licenses/by-nc-nd/4.0/ info:eu-repo/semantics/openAccess |
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http://creativecommons.org/licenses/by-nc-nd/4.0/ |
eu_rights_str_mv |
openAccess |
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dc.publisher.none.fl_str_mv |
Universidade Federal de Goiás |
dc.publisher.program.fl_str_mv |
Programa de Pós-graduação em Ciências da Saúde (FM) |
dc.publisher.initials.fl_str_mv |
UFG |
dc.publisher.country.fl_str_mv |
Brasil |
dc.publisher.department.fl_str_mv |
Faculdade de Medicina - FM (RG) |
publisher.none.fl_str_mv |
Universidade Federal de Goiás |
dc.source.none.fl_str_mv |
reponame:Repositório Institucional da UFG instname:Universidade Federal de Goiás (UFG) instacron:UFG |
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Universidade Federal de Goiás (UFG) |
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UFG |
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Repositório Institucional da UFG |
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