Obtenção e caracterização química e farmacocinética do produto de fotodegradação do nifedipino

Detalhes bibliográficos
Autor(a) principal: Oliveira, Maysa Aparecida de
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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spelling 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). 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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
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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
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language por
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dc.relation.confidence.fl_str_mv 600
600
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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
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