Determinação analítica e estudo da liberação in vitro de meloxicam em comprimidos/

Detalhes bibliográficos
Ano de defesa: 2009
Autor(a) principal: Oliveira, Érika De Fátima Silva lattes
Orientador(a): Araújo, Magali Benjamim De lattes
Banca de defesa: Pereira, Gislaine Ribeiro, Kedor-Hackmann, Erika Rosa Maria
Tipo de documento: Dissertação
Tipo de acesso: Acesso aberto
Idioma: por
Instituição de defesa: Universidade Federal de Alfenas
Programa de Pós-Graduação: Programa de Pós-Graduação em Ciências Farmacêuticas
Departamento: Faculdade de Ciências Farmacêuticas
País: Brasil
Palavras-chave em Português:
Área do conhecimento CNPq:
Link de acesso: https://repositorio.unifal-mg.edu.br/handle/123456789/749
Resumo: Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve the signs and symptoms of osteoarthritis and rheumatoid arthritis in adults. No official method is available for the assay of drug in pharmaceutical formulations. The aim of this study was to develop and validate analytical methods for meloxicam quantification in tablets and then establish conditions for accomplishment of the test of dissolution of meloxicam tablets 15 mg. A spectrophotometric method was proposed employing two solvents: methanol and 0.1 M sodium hydroxide. Absorbances were performed at 356nm and 362nm, respectively. In addiction to spectrophotometric, an HPLC method was proposed for the estimation of meloxicam in tablets (mixture of pH 4.5 potasium phosphate buffer and acetonitrile 60:40, v/v, as mobile phase, UV detection at 364 nm, C18, 3 mm column, to 30ºC, run at a flow rate of 1 mLmin-1 and retention time around 2.6 min). To establish the conditions for accomplishment of the test of meloxicam dissolution were employed the reference product and products tests A and B. Several parameters were tested, the use of pH 7.5, 0.02 M phosphate buffer (900mL, to 37 ºC ± 0.5 ºC) as dissolution medium, paddle method (apparatus 2) and stirring speed of agitation of the dissolution medium of 100 rpm and collect time in 60 minutes were considered satisfactory. The samples were quantified by UV spectrophotometric method at 362 nm. In relation to the dissolution kinetics all of the products presented kinetics of first order. For the dissolution efficiency values were of 83.25 %, 83.73 % and 88.10 % for the A, B and reference products, respectively. The factors f1 and f2 were calculated demonstrating there to be similarity of the appraised medicines. The dissolution procedure in the conditions selected and the proposed methods can be used for quantification of meloxicam in tablets with selectivity, linearity, precision, accuracy and robustness.
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spelling Oliveira, Érika De Fátima Silvahttp://lattes.cnpq.br/5033189741354139Pereira, Gislaine RibeiroKedor-Hackmann, Erika Rosa MariaAraújo, Magali Benjamim Dehttp://lattes.cnpq.br/50440624557545792015-12-10T22:56:43Z2009-07-01OLIVEIRA, Érika de Fátima Silva. Análise da atividade biológica de própolis de uruçu (Melipona scutellaris) do Estado da Bahia. 2009. 142 f. Dissertação (Mestrado em Ciências Farmacêuticas) - Universidade Federal de Alfenas, Alfenas, MG, 2009.https://repositorio.unifal-mg.edu.br/handle/123456789/749Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve the signs and symptoms of osteoarthritis and rheumatoid arthritis in adults. No official method is available for the assay of drug in pharmaceutical formulations. The aim of this study was to develop and validate analytical methods for meloxicam quantification in tablets and then establish conditions for accomplishment of the test of dissolution of meloxicam tablets 15 mg. A spectrophotometric method was proposed employing two solvents: methanol and 0.1 M sodium hydroxide. Absorbances were performed at 356nm and 362nm, respectively. In addiction to spectrophotometric, an HPLC method was proposed for the estimation of meloxicam in tablets (mixture of pH 4.5 potasium phosphate buffer and acetonitrile 60:40, v/v, as mobile phase, UV detection at 364 nm, C18, 3 mm column, to 30ºC, run at a flow rate of 1 mLmin-1 and retention time around 2.6 min). To establish the conditions for accomplishment of the test of meloxicam dissolution were employed the reference product and products tests A and B. Several parameters were tested, the use of pH 7.5, 0.02 M phosphate buffer (900mL, to 37 ºC ± 0.5 ºC) as dissolution medium, paddle method (apparatus 2) and stirring speed of agitation of the dissolution medium of 100 rpm and collect time in 60 minutes were considered satisfactory. The samples were quantified by UV spectrophotometric method at 362 nm. In relation to the dissolution kinetics all of the products presented kinetics of first order. For the dissolution efficiency values were of 83.25 %, 83.73 % and 88.10 % for the A, B and reference products, respectively. The factors f1 and f2 were calculated demonstrating there to be similarity of the appraised medicines. The dissolution procedure in the conditions selected and the proposed methods can be used for quantification of meloxicam in tablets with selectivity, linearity, precision, accuracy and robustness.O meloxicam é um fármaco antiinflamatório não-esteroidal (AINE) usado para aliviar os sinais e sintomas da osteoartrite e artrite reumatóide em adultos. Não há método oficial para quantificação do fármaco em formulações farmacêuticas. O objetivo deste estudo foi desenvolver e validar métodos analíticos para quantificação de meloxicam em comprimidos e ainda estabelecer condições para realização do teste de dissolução de comprimidos de meloxicam 15 mg. Um método espectrofotométrico foi proposto, empregando-se dois solventes: metanol e hidróxido de sódio 0,1M. As leituras das absorvâncias foram efetuadas a 356 nm e 362 nm, respectivamente. Além do método espectrofotométrico, um método por CLAE foi desenvolvido, para determinação de meloxicam em comprimidos (mistura de tampão fosfato de potássio pH 4,5 e acetonitrila 60:40, v/v como fase móvel, coluna C18, 3 mm, a 30ºC, vazão de 1 mLmin-1 e tempo de retenção em torno de 2,6 min). Para estabelecer as condições para o teste de dissolução, empregou-se o medicamento referência e dois produtos teste A e B. Vários parâmetros foram testados, o uso de tampão fosfato 0,02 M, pH 7,5 (900mL, a 37ºC ± 0.5ºC) como meio de dissolução, aparato 2 (pá) e velocidade de agitação do meio de dissolução de 100 rpm, foram consideradas satisfatórias. As amostras foram quantificadas por espectrofotometria no UV a 362 nm. Em relação à cinética de dissolução, todos os produtos apresentaram cinética de primeira ordem. Os valores obtidos para a eficiência de dissolução foram de 83,25 %, 83,73 % e 88,10 % para os medicamentos A, B e de referência, respectivamente. Os fatores f1 e f2 foram calculados e demonstraram haver similaridade entre os medicamentos avaliados. O procedimento de dissolução nas condições selecionadas apresentou-se seletivo, linear, preciso e exato. Tanto o procedimento de dissolução nas condições selecionadas, quanto os métodos propostos podem ser utilizados para quantificação de meloxicam em comprimidos, com seletividade, linearidade, precisão, exatidão e robustez.application/pdfporUniversidade Federal de AlfenasPrograma de Pós-Graduação em Ciências FarmacêuticasUNIFAL-MGBrasilFaculdade de Ciências Farmacêuticasinfo:eu-repo/semantics/openAccesshttp://creativecommons.org/licenses/by-nc-nd/4.0/MeloxicamComprimidosCIENCIAS DA SAUDE::FARMACIADeterminação analítica e estudo da liberação in vitro de meloxicam em comprimidos/info:eu-repo/semantics/masterThesisinfo:eu-repo/semantics/publishedVersion-64258451559862442976006006997636413449754996reponame:Repositório Institucional da Universidade Federal de Alfenas - RiUnifalinstname:Universidade Federal de Alfenas (UNIFAL)instacron:UNIFALOliveira, Érika De Fátima SilvaLICENSElicense.txtlicense.txttext/plain; charset=utf-81987https://repositorio.unifal-mg.edu.br/bitstreams/e668e4e8-a3d2-4ce0-b23e-ef769286bb91/download31555718c4fc75849dd08f27935d4f6bMD51CC-LICENSElicense_urllicense_urltext/plain; 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dc.title.pt-BR.fl_str_mv Determinação analítica e estudo da liberação in vitro de meloxicam em comprimidos/
title Determinação analítica e estudo da liberação in vitro de meloxicam em comprimidos/
spellingShingle Determinação analítica e estudo da liberação in vitro de meloxicam em comprimidos/
Oliveira, Érika De Fátima Silva
Meloxicam
Comprimidos
CIENCIAS DA SAUDE::FARMACIA
title_short Determinação analítica e estudo da liberação in vitro de meloxicam em comprimidos/
title_full Determinação analítica e estudo da liberação in vitro de meloxicam em comprimidos/
title_fullStr Determinação analítica e estudo da liberação in vitro de meloxicam em comprimidos/
title_full_unstemmed Determinação analítica e estudo da liberação in vitro de meloxicam em comprimidos/
title_sort Determinação analítica e estudo da liberação in vitro de meloxicam em comprimidos/
author Oliveira, Érika De Fátima Silva
author_facet Oliveira, Érika De Fátima Silva
author_role author
dc.contributor.author.fl_str_mv Oliveira, Érika De Fátima Silva
dc.contributor.advisor1Lattes.fl_str_mv http://lattes.cnpq.br/5033189741354139
dc.contributor.referee1.fl_str_mv Pereira, Gislaine Ribeiro
dc.contributor.referee2.fl_str_mv Kedor-Hackmann, Erika Rosa Maria
dc.contributor.advisor1.fl_str_mv Araújo, Magali Benjamim De
dc.contributor.authorLattes.fl_str_mv http://lattes.cnpq.br/5044062455754579
contributor_str_mv Pereira, Gislaine Ribeiro
Kedor-Hackmann, Erika Rosa Maria
Araújo, Magali Benjamim De
dc.subject.por.fl_str_mv Meloxicam
Comprimidos
topic Meloxicam
Comprimidos
CIENCIAS DA SAUDE::FARMACIA
dc.subject.cnpq.fl_str_mv CIENCIAS DA SAUDE::FARMACIA
description Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve the signs and symptoms of osteoarthritis and rheumatoid arthritis in adults. No official method is available for the assay of drug in pharmaceutical formulations. The aim of this study was to develop and validate analytical methods for meloxicam quantification in tablets and then establish conditions for accomplishment of the test of dissolution of meloxicam tablets 15 mg. A spectrophotometric method was proposed employing two solvents: methanol and 0.1 M sodium hydroxide. Absorbances were performed at 356nm and 362nm, respectively. In addiction to spectrophotometric, an HPLC method was proposed for the estimation of meloxicam in tablets (mixture of pH 4.5 potasium phosphate buffer and acetonitrile 60:40, v/v, as mobile phase, UV detection at 364 nm, C18, 3 mm column, to 30ºC, run at a flow rate of 1 mLmin-1 and retention time around 2.6 min). To establish the conditions for accomplishment of the test of meloxicam dissolution were employed the reference product and products tests A and B. Several parameters were tested, the use of pH 7.5, 0.02 M phosphate buffer (900mL, to 37 ºC ± 0.5 ºC) as dissolution medium, paddle method (apparatus 2) and stirring speed of agitation of the dissolution medium of 100 rpm and collect time in 60 minutes were considered satisfactory. The samples were quantified by UV spectrophotometric method at 362 nm. In relation to the dissolution kinetics all of the products presented kinetics of first order. For the dissolution efficiency values were of 83.25 %, 83.73 % and 88.10 % for the A, B and reference products, respectively. The factors f1 and f2 were calculated demonstrating there to be similarity of the appraised medicines. The dissolution procedure in the conditions selected and the proposed methods can be used for quantification of meloxicam in tablets with selectivity, linearity, precision, accuracy and robustness.
publishDate 2009
dc.date.issued.fl_str_mv 2009-07-01
dc.date.accessioned.fl_str_mv 2015-12-10T22:56:43Z
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dc.identifier.citation.fl_str_mv OLIVEIRA, Érika de Fátima Silva. Análise da atividade biológica de própolis de uruçu (Melipona scutellaris) do Estado da Bahia. 2009. 142 f. Dissertação (Mestrado em Ciências Farmacêuticas) - Universidade Federal de Alfenas, Alfenas, MG, 2009.
dc.identifier.uri.fl_str_mv https://repositorio.unifal-mg.edu.br/handle/123456789/749
identifier_str_mv OLIVEIRA, Érika de Fátima Silva. Análise da atividade biológica de própolis de uruçu (Melipona scutellaris) do Estado da Bahia. 2009. 142 f. Dissertação (Mestrado em Ciências Farmacêuticas) - Universidade Federal de Alfenas, Alfenas, MG, 2009.
url https://repositorio.unifal-mg.edu.br/handle/123456789/749
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