Desenvolvimento de metodologia para avaliação da liberação in vitro e controle de qualidade de diclofenaco potássico suspensão oral
Autor(a) principal: | |
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Data de Publicação: | 2013 |
Tipo de documento: | Dissertação |
Idioma: | por |
Título da fonte: | Repositório Institucional Manancial UFSM |
Texto Completo: | http://repositorio.ufsm.br/handle/1/5962 |
Resumo: | The diclofenac potassium (DPt) is a derivate of phenylacetic acid, with proprietary anti-inflammatory, analgesic and antipyretic, thus indicated for the relief of low back pain, rheumatoid arthritis and postoperative pain. The DPt is in the market for oral suspension dosage forms, dragee, suppository, injectable solution, dispersible tablet and tablet. However not been found in literature analytical method for determination of DPt in oral suspension. There are also no reports of methods for evaluating the in vitro dissolution of oral suspension containing the drug. Thus, in the present work were developed and validated methods by liquid chromatography high efficiency for the quantification and assessment of drug dissolution in oral suspension. Quantification of DPt was performed using column C8, mobile phase consisting of methanol and phosphate buffer pH 2.5 with a flow rate of 1.0 mL/min. The quantitative method was shown to be specific, even in the presence of possible degradation products, good linearity (r = 1.0), precise (RSD < 2.0%) and having adequate accuracy and robustness. The drug demonstrated to be stable under alkaline conditions and high temperature, but showed instability when exposed to conditions acid, oxidative and in the presence of ultraviolet radiation. To develop the method of dissolving the best conditions were 900 mL of aqueous solution containing 0.3% of sodium laurylsulfate, maintained at 37.0 ± 0.5 ºC, using paddle apparatus with rotation speed of 50 rpm. Thus, the release of DPt was greater than 85.0% at 30 minutes for both batches evaluated. The validated method proved to be specific, linear (r > 0.99), and showed precision and accuracy satisfactory. We also evaluated the stability of the drug in the dissolution medium selected, and the possible adsorption of the drug on the paper filter used. For both the test results were satisfactory. Thus, the methods developed and validated may be used as routine methods in quality control for the quantification and evaluation of the dissolution profile of DPt oral suspension. |
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2015-01-292015-01-292013-01-16RUBIM, Alexandre Machado. DEVELOPMENT OF METHODOLOGY FOR EVALUATION OF LIBERATION IN VITRO AND QUALITY CONTROL OF DICLOFENAC POTASSIUM ORAL SUSPENSION. 2013. 98 f. Dissertação (Mestrado em Farmacologia) - Universidade Federal de Santa Maria, Santa Maria, 2013.http://repositorio.ufsm.br/handle/1/5962The diclofenac potassium (DPt) is a derivate of phenylacetic acid, with proprietary anti-inflammatory, analgesic and antipyretic, thus indicated for the relief of low back pain, rheumatoid arthritis and postoperative pain. The DPt is in the market for oral suspension dosage forms, dragee, suppository, injectable solution, dispersible tablet and tablet. However not been found in literature analytical method for determination of DPt in oral suspension. There are also no reports of methods for evaluating the in vitro dissolution of oral suspension containing the drug. Thus, in the present work were developed and validated methods by liquid chromatography high efficiency for the quantification and assessment of drug dissolution in oral suspension. Quantification of DPt was performed using column C8, mobile phase consisting of methanol and phosphate buffer pH 2.5 with a flow rate of 1.0 mL/min. The quantitative method was shown to be specific, even in the presence of possible degradation products, good linearity (r = 1.0), precise (RSD < 2.0%) and having adequate accuracy and robustness. The drug demonstrated to be stable under alkaline conditions and high temperature, but showed instability when exposed to conditions acid, oxidative and in the presence of ultraviolet radiation. To develop the method of dissolving the best conditions were 900 mL of aqueous solution containing 0.3% of sodium laurylsulfate, maintained at 37.0 ± 0.5 ºC, using paddle apparatus with rotation speed of 50 rpm. Thus, the release of DPt was greater than 85.0% at 30 minutes for both batches evaluated. The validated method proved to be specific, linear (r > 0.99), and showed precision and accuracy satisfactory. We also evaluated the stability of the drug in the dissolution medium selected, and the possible adsorption of the drug on the paper filter used. For both the test results were satisfactory. Thus, the methods developed and validated may be used as routine methods in quality control for the quantification and evaluation of the dissolution profile of DPt oral suspension.O diclofenaco potássico (DPt), fármaco derivado do ácido fenilacético, apresenta propriedade anti-inflamatória, analgésica e antitérmica, sendo assim indicado para o alívio da dor na região lombar, artrite reumatoide e dor pós-operatória. O DPt encontra-se no mercado nas formas farmacêuticas de suspensão oral, drágea, supositório, solução injetável, comprimido dispersível e comprimido, no entanto não foram encontrados na literatura métodos analíticos para determinação de DPt em suspensão oral. Também não há relatos de métodos para avaliação da dissolução in vitro de suspensão oral contendo este fármaco. Desta forma, no presente trabalho foram desenvolvidos e validados métodos por cromatografia a líquido de alta eficiência para quantificação e avaliação da porcentagem dissolvida do fármaco. A determinação quantitativa foi realizada utilizando coluna C8, fase móvel composta de metanol e tampão fosfato pH 2,5 e fluxo de 1,0 mL/min. O método quantitativo apresentou ser especifico, mesmo na presença de possíveis produtos de degradação, boa linearidade (r = 1,0), preciso (DPR < 2,0%) ser exato e robusto. O fármaco demonstrou ser estável em condições alcalinas e a alta temperatura, porém demonstrou instabilidade quando exposto a condições ácidas, oxidativas e na presença da radiação ultravioleta. Para o desenvolvimento do método de dissolução utilizou-se como meio 900 mL de solução aquosa contendo 0,3% de laurilsulfato de sódio, mantida a 37,0 ± 0,5 ºC, utilizando aparato pá com velocidade de rotação de 50 rpm. Nestas condições, a liberação de DPt foi superior a 85,0% em 30 minutos para ambos os lotes avaliados. O método validado demonstrou ser específico, linear (r > 0,99), e apresentou precisão e exatidão satisfatórias. Também se avaliou a estabilidade do fármaco no meio de dissolução, assim como a possível adsorção do fármaco no papel de filtração utilizado. Para ambos os ensaios os resultados encontrados foram satisfatórios. Desta forma, os métodos desenvolvidos e validados podem ser utilizados como métodos de rotina no controle de qualidade para quantificação e avaliação do perfil de dissolução de DPt suspensão oral.application/pdfporUniversidade Federal de Santa MariaPrograma de Pós-Graduação em Ciências FarmacêuticasUFSMBRFarmáciaDissoluçãoDiclofenaco potássicoCromatografia a Líquido de Alta Eficiência (CLAE)Suspensão oralDissolutionDiclofenac potassiumHigh performance liquid chromatography (HPLC)Oral suspensionCNPQ::CIENCIAS DA SAUDE::FARMACIADesenvolvimento de metodologia para avaliação da liberação in vitro e controle de qualidade de diclofenaco potássico suspensão oralDevelopment of methodology for evaluation of liberation in vitro and quality control of diclofenac potassium oral suspensioninfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/masterThesisRolim, Clarice Madalena Buenohttp://lattes.cnpq.br/2270654658839508Alves, Marta Palmahttp://lattes.cnpq.br/0896057648821138Gomes, Patríciahttp://lattes.cnpq.br/7622203730579234http://lattes.cnpq.br/2857969695327738Rubim, Alexandre Machado201000000000400300300500500dced70fb-2e68-45f2-9d89-dc395bc6c034e4ac3d13-ecaa-4b35-84a9-0db7515625855601655b-0a2c-4c7e-a7fc-8f93bb630ba3ef9eef3d-25fd-4747-ae4d-5fed54a703b1info:eu-repo/semantics/openAccessreponame:Repositório Institucional Manancial UFSMinstname:Universidade Federal de Santa Maria (UFSM)instacron:UFSMORIGINALRUBIN, ALEXANDRE MACHADO.pdfapplication/pdf2130163http://repositorio.ufsm.br/bitstream/1/5962/1/RUBIN%2c%20ALEXANDRE%20MACHADO.pdf4958a7b58afabfaca72fbc8c4b943143MD51TEXTRUBIN, ALEXANDRE MACHADO.pdf.txtRUBIN, ALEXANDRE MACHADO.pdf.txtExtracted texttext/plain163619http://repositorio.ufsm.br/bitstream/1/5962/2/RUBIN%2c%20ALEXANDRE%20MACHADO.pdf.txtf4c21ffe1b4243d947290c47c6e41010MD52THUMBNAILRUBIN, ALEXANDRE MACHADO.pdf.jpgRUBIN, ALEXANDRE MACHADO.pdf.jpgIM Thumbnailimage/jpeg5255http://repositorio.ufsm.br/bitstream/1/5962/3/RUBIN%2c%20ALEXANDRE%20MACHADO.pdf.jpg625849c7bd7c9e3b2c1d14e333da96cbMD531/59622022-10-19 12:24:40.794oai:repositorio.ufsm.br:1/5962Repositório Institucionalhttp://repositorio.ufsm.br/PUBhttp://repositorio.ufsm.br/oai/requestouvidoria@ufsm.bropendoar:39132022-10-19T15:24:40Repositório Institucional Manancial UFSM - Universidade Federal de Santa Maria (UFSM)false |
dc.title.por.fl_str_mv |
Desenvolvimento de metodologia para avaliação da liberação in vitro e controle de qualidade de diclofenaco potássico suspensão oral |
dc.title.alternative.eng.fl_str_mv |
Development of methodology for evaluation of liberation in vitro and quality control of diclofenac potassium oral suspension |
title |
Desenvolvimento de metodologia para avaliação da liberação in vitro e controle de qualidade de diclofenaco potássico suspensão oral |
spellingShingle |
Desenvolvimento de metodologia para avaliação da liberação in vitro e controle de qualidade de diclofenaco potássico suspensão oral Rubim, Alexandre Machado Dissolução Diclofenaco potássico Cromatografia a Líquido de Alta Eficiência (CLAE) Suspensão oral Dissolution Diclofenac potassium High performance liquid chromatography (HPLC) Oral suspension CNPQ::CIENCIAS DA SAUDE::FARMACIA |
title_short |
Desenvolvimento de metodologia para avaliação da liberação in vitro e controle de qualidade de diclofenaco potássico suspensão oral |
title_full |
Desenvolvimento de metodologia para avaliação da liberação in vitro e controle de qualidade de diclofenaco potássico suspensão oral |
title_fullStr |
Desenvolvimento de metodologia para avaliação da liberação in vitro e controle de qualidade de diclofenaco potássico suspensão oral |
title_full_unstemmed |
Desenvolvimento de metodologia para avaliação da liberação in vitro e controle de qualidade de diclofenaco potássico suspensão oral |
title_sort |
Desenvolvimento de metodologia para avaliação da liberação in vitro e controle de qualidade de diclofenaco potássico suspensão oral |
author |
Rubim, Alexandre Machado |
author_facet |
Rubim, Alexandre Machado |
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 |
Alves, Marta Palma |
dc.contributor.referee1Lattes.fl_str_mv |
http://lattes.cnpq.br/0896057648821138 |
dc.contributor.referee2.fl_str_mv |
Gomes, Patrícia |
dc.contributor.referee2Lattes.fl_str_mv |
http://lattes.cnpq.br/7622203730579234 |
dc.contributor.authorLattes.fl_str_mv |
http://lattes.cnpq.br/2857969695327738 |
dc.contributor.author.fl_str_mv |
Rubim, Alexandre Machado |
contributor_str_mv |
Rolim, Clarice Madalena Bueno Alves, Marta Palma Gomes, Patrícia |
dc.subject.por.fl_str_mv |
Dissolução Diclofenaco potássico Cromatografia a Líquido de Alta Eficiência (CLAE) Suspensão oral |
topic |
Dissolução Diclofenaco potássico Cromatografia a Líquido de Alta Eficiência (CLAE) Suspensão oral Dissolution Diclofenac potassium High performance liquid chromatography (HPLC) Oral suspension CNPQ::CIENCIAS DA SAUDE::FARMACIA |
dc.subject.eng.fl_str_mv |
Dissolution Diclofenac potassium High performance liquid chromatography (HPLC) Oral suspension |
dc.subject.cnpq.fl_str_mv |
CNPQ::CIENCIAS DA SAUDE::FARMACIA |
description |
The diclofenac potassium (DPt) is a derivate of phenylacetic acid, with proprietary anti-inflammatory, analgesic and antipyretic, thus indicated for the relief of low back pain, rheumatoid arthritis and postoperative pain. The DPt is in the market for oral suspension dosage forms, dragee, suppository, injectable solution, dispersible tablet and tablet. However not been found in literature analytical method for determination of DPt in oral suspension. There are also no reports of methods for evaluating the in vitro dissolution of oral suspension containing the drug. Thus, in the present work were developed and validated methods by liquid chromatography high efficiency for the quantification and assessment of drug dissolution in oral suspension. Quantification of DPt was performed using column C8, mobile phase consisting of methanol and phosphate buffer pH 2.5 with a flow rate of 1.0 mL/min. The quantitative method was shown to be specific, even in the presence of possible degradation products, good linearity (r = 1.0), precise (RSD < 2.0%) and having adequate accuracy and robustness. The drug demonstrated to be stable under alkaline conditions and high temperature, but showed instability when exposed to conditions acid, oxidative and in the presence of ultraviolet radiation. To develop the method of dissolving the best conditions were 900 mL of aqueous solution containing 0.3% of sodium laurylsulfate, maintained at 37.0 ± 0.5 ºC, using paddle apparatus with rotation speed of 50 rpm. Thus, the release of DPt was greater than 85.0% at 30 minutes for both batches evaluated. The validated method proved to be specific, linear (r > 0.99), and showed precision and accuracy satisfactory. We also evaluated the stability of the drug in the dissolution medium selected, and the possible adsorption of the drug on the paper filter used. For both the test results were satisfactory. Thus, the methods developed and validated may be used as routine methods in quality control for the quantification and evaluation of the dissolution profile of DPt oral suspension. |
publishDate |
2013 |
dc.date.issued.fl_str_mv |
2013-01-16 |
dc.date.accessioned.fl_str_mv |
2015-01-29 |
dc.date.available.fl_str_mv |
2015-01-29 |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/masterThesis |
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masterThesis |
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dc.identifier.citation.fl_str_mv |
RUBIM, Alexandre Machado. DEVELOPMENT OF METHODOLOGY FOR EVALUATION OF LIBERATION IN VITRO AND QUALITY CONTROL OF DICLOFENAC POTASSIUM ORAL SUSPENSION. 2013. 98 f. Dissertação (Mestrado em Farmacologia) - Universidade Federal de Santa Maria, Santa Maria, 2013. |
dc.identifier.uri.fl_str_mv |
http://repositorio.ufsm.br/handle/1/5962 |
identifier_str_mv |
RUBIM, Alexandre Machado. DEVELOPMENT OF METHODOLOGY FOR EVALUATION OF LIBERATION IN VITRO AND QUALITY CONTROL OF DICLOFENAC POTASSIUM ORAL SUSPENSION. 2013. 98 f. Dissertação (Mestrado em Farmacologia) - Universidade Federal de Santa Maria, Santa Maria, 2013. |
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