Azitromicina: desenvolvimento e validação de métodos de análise em formas farmacêuticas
Autor(a) principal: | |
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Data de Publicação: | 2007 |
Tipo de documento: | Dissertação |
Idioma: | por |
Título da fonte: | Repositório Institucional Manancial UFSM |
Texto Completo: | http://repositorio.ufsm.br/handle/1/6030 |
Resumo: | Azithromycin (AZ) is a macrolide antibiotic derivate from erytromycin. AZ has a broad spectrum of activity against common gram-negative pathogens and has been used for the treatment of respiratory tract infection, skin infections and sexually transmitted diseases. In the Brazilian market AZ is available as tablets, compounded capsules and powder for oral suspension. The official methods for the assay of AZ in bulk form; capsules and powder for oral suspension are high performance liquid chromatography or microbiological diffusion assay. No monographs are reported in the pharmacopoeias for AZ evaluation in tablets. In this work two spectrophotometric methods were developed and validated for AZ analysis in tablets and powder for oral suspension. The first method was based on the reaction of AZ with concentrated sulfuric acid (98 % w/v), with detection at 226 nm. The other method was based in the charge-transfer reaction of the drug with s-acceptor iodine, with detection at 363 nm. Both methods showed good linearity (r>0.99), precision (CV<5%) and accuracy (>99%). The results obtained with the proposed methods were in good agreement with those obtained by microbiological diffusion agar method. The optimization of dissolution test conditions for in vitro quality control of AZ in tablets was also studied. The use of 900 mL of 0.1N HCl at 37.0 ± 0.5 ºC, paddle as apparatus, at a stirring rate of 50 rpm, provided satisfactory results for tested products. The percent dissolution of AZ in the established condition was more than 90% in 45 minutes. The validated spectrophotometric method used to evaluate the dissolution testing showed to be specific (with no interference of the placebo or tablets in the quantification of AZ), linear (r>0.99), precise (RSD<5%) and accurate (>97%). The drug showed satisfactory stability in the selected dissolution medium |
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2007-07-032007-07-032007-05-04FERREIRA, João Ronaldo Notargiacomo. Azithromycin: development and validation of analysis methods in pharmaceutical dosage forms. 2007. 99 f. Dissertação (Mestrado em Farmacologia) - Universidade Federal de Santa Maria, Santa Maria, 2007.http://repositorio.ufsm.br/handle/1/6030Azithromycin (AZ) is a macrolide antibiotic derivate from erytromycin. AZ has a broad spectrum of activity against common gram-negative pathogens and has been used for the treatment of respiratory tract infection, skin infections and sexually transmitted diseases. In the Brazilian market AZ is available as tablets, compounded capsules and powder for oral suspension. The official methods for the assay of AZ in bulk form; capsules and powder for oral suspension are high performance liquid chromatography or microbiological diffusion assay. No monographs are reported in the pharmacopoeias for AZ evaluation in tablets. In this work two spectrophotometric methods were developed and validated for AZ analysis in tablets and powder for oral suspension. The first method was based on the reaction of AZ with concentrated sulfuric acid (98 % w/v), with detection at 226 nm. The other method was based in the charge-transfer reaction of the drug with s-acceptor iodine, with detection at 363 nm. Both methods showed good linearity (r>0.99), precision (CV<5%) and accuracy (>99%). The results obtained with the proposed methods were in good agreement with those obtained by microbiological diffusion agar method. The optimization of dissolution test conditions for in vitro quality control of AZ in tablets was also studied. The use of 900 mL of 0.1N HCl at 37.0 ± 0.5 ºC, paddle as apparatus, at a stirring rate of 50 rpm, provided satisfactory results for tested products. The percent dissolution of AZ in the established condition was more than 90% in 45 minutes. The validated spectrophotometric method used to evaluate the dissolution testing showed to be specific (with no interference of the placebo or tablets in the quantification of AZ), linear (r>0.99), precise (RSD<5%) and accurate (>97%). The drug showed satisfactory stability in the selected dissolution mediumAzitromicina (AZ) é um antibiótico macrolídeo derivado da eritromicina. AZ apresenta um grande espectro de atividade contra patógenos Gram negativos comuns e tem sido utilizada para o tratamento de infecções do trato respiratório, infecções da pele e doenças sexualmente transmissíveis. No mercado brasileiro a AZ está disponível na forma de comprimidos, cápsulas manipuladas e pó para suspensão oral. Os métodos oficiais para o doseamento de AZ como matéria-prima; cápsulas e pó para a suspensão oral são a cromatografia líquida de alta eficiência ou o método microbiológico de difusão em ágar. Não existem monografias em farmacopéias para avaliação de AZ em comprimidos. Neste trabalho dois métodos espectrofotométricos foram desenvolvidos e validados para a análise de AZ em comprimidos e em pó para suspensão oral. O primeiro método foi baseado na reação de AZ com ácido sulfúrico concentrado (98%, p/v), com detecção em 226 nm. O outro método foi baseado na reação de complexo de transferência de carga do fármaco com o s-aceptor iodo, com detecção em 363 nm. Ambos os métodos mostraram linearidade (r>0,99), precisão (CV<5%) e exatidão (>99%). Os resultados obtidos com os métodos propostos estavam de acordo com aqueles obtidos com o método microbiológico de difusão em ágar. A otimização das condições do teste de dissolução para o controle de qualidade in vitro de AZ em comprimidos foi também estudado. O uso de 900 mL de HCl 0,1N, a 37 ºC ± 0,5 ºC, aparato pá, a um a velocidade de 50 rpm, demonstrou resultados satisfatórios para produtos testados. A percentagem de dissolução de AZ na condição estabelecida foi superior a 90% em 45 minutos. O método espectrofotométrico validado para avaliar a dissolução mostrou-se específico, sem interferência do placebo dos comprimidos, na quantificação de AZ, linear (r>0.99), preciso (CV< 5%) e exato (>97%). O fármaco mostrou estabilidade satisfatória no meio de dissolução selecionadoapplication/pdfporUniversidade Federal de Santa MariaPrograma de Pós-Graduação em Ciências FarmacêuticasUFSMBRFarmáciaAzitromicinaEspectrofotometriaValidaçãoDissoluçãoAzithromycinSpectrophotometryValidationDissolutionCNPQ::CIENCIAS DA SAUDE::FARMACIAAzitromicina: desenvolvimento e validação de métodos de análise em formas farmacêuticasAzithromycin: development and validation of analysis methods in pharmaceutical dosage formsinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/masterThesisCardoso, Simone Gonçalveshttp://lattes.cnpq.br/0137281979458686Silva, Marcos Antonio Segattohttp://lattes.cnpq.br/3411646377586063Silva, Elisabete de Avila dahttp://lattes.cnpq.br/0077152291293677http://lattes.cnpq.br/4512442324439070Ferreira, João Ronaldo Notargiacomo2010000000004003003003003006758404a-9869-4ba3-bc4f-6a323a52575a37fe693f-16b2-413a-9005-41287a6ff983967ca0dd-5d6d-4863-8125-21606c760b9d7f7170ee-a33e-4ab7-867a-9057e8e920cbinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional Manancial UFSMinstname:Universidade Federal de Santa Maria (UFSM)instacron:UFSMORIGINALjoao.pdfapplication/pdf1064021http://repositorio.ufsm.br/bitstream/1/6030/1/joao.pdfe2704b36eab0fda6b452d7e6354b232bMD51TEXTjoao.pdf.txtjoao.pdf.txtExtracted texttext/plain171413http://repositorio.ufsm.br/bitstream/1/6030/2/joao.pdf.txtc0cab3a2ca41373ae998541a79d289d6MD52THUMBNAILjoao.pdf.jpgjoao.pdf.jpgIM Thumbnailimage/jpeg4946http://repositorio.ufsm.br/bitstream/1/6030/3/joao.pdf.jpge4e006e0e7011f99ed94e6908f133da9MD531/60302023-01-06 13:48:40.286oai:repositorio.ufsm.br:1/6030Repositório Institucionalhttp://repositorio.ufsm.br/PUBhttp://repositorio.ufsm.br/oai/requestouvidoria@ufsm.bropendoar:39132023-01-06T16:48:40Repositório Institucional Manancial UFSM - Universidade Federal de Santa Maria (UFSM)false |
dc.title.por.fl_str_mv |
Azitromicina: desenvolvimento e validação de métodos de análise em formas farmacêuticas |
dc.title.alternative.eng.fl_str_mv |
Azithromycin: development and validation of analysis methods in pharmaceutical dosage forms |
title |
Azitromicina: desenvolvimento e validação de métodos de análise em formas farmacêuticas |
spellingShingle |
Azitromicina: desenvolvimento e validação de métodos de análise em formas farmacêuticas Ferreira, João Ronaldo Notargiacomo Azitromicina Espectrofotometria Validação Dissolução Azithromycin Spectrophotometry Validation Dissolution CNPQ::CIENCIAS DA SAUDE::FARMACIA |
title_short |
Azitromicina: desenvolvimento e validação de métodos de análise em formas farmacêuticas |
title_full |
Azitromicina: desenvolvimento e validação de métodos de análise em formas farmacêuticas |
title_fullStr |
Azitromicina: desenvolvimento e validação de métodos de análise em formas farmacêuticas |
title_full_unstemmed |
Azitromicina: desenvolvimento e validação de métodos de análise em formas farmacêuticas |
title_sort |
Azitromicina: desenvolvimento e validação de métodos de análise em formas farmacêuticas |
author |
Ferreira, João Ronaldo Notargiacomo |
author_facet |
Ferreira, João Ronaldo Notargiacomo |
author_role |
author |
dc.contributor.advisor1.fl_str_mv |
Cardoso, Simone Gonçalves |
dc.contributor.advisor1Lattes.fl_str_mv |
http://lattes.cnpq.br/0137281979458686 |
dc.contributor.referee1.fl_str_mv |
Silva, Marcos Antonio Segatto |
dc.contributor.referee1Lattes.fl_str_mv |
http://lattes.cnpq.br/3411646377586063 |
dc.contributor.referee2.fl_str_mv |
Silva, Elisabete de Avila da |
dc.contributor.referee2Lattes.fl_str_mv |
http://lattes.cnpq.br/0077152291293677 |
dc.contributor.authorLattes.fl_str_mv |
http://lattes.cnpq.br/4512442324439070 |
dc.contributor.author.fl_str_mv |
Ferreira, João Ronaldo Notargiacomo |
contributor_str_mv |
Cardoso, Simone Gonçalves Silva, Marcos Antonio Segatto Silva, Elisabete de Avila da |
dc.subject.por.fl_str_mv |
Azitromicina Espectrofotometria Validação Dissolução |
topic |
Azitromicina Espectrofotometria Validação Dissolução Azithromycin Spectrophotometry Validation Dissolution CNPQ::CIENCIAS DA SAUDE::FARMACIA |
dc.subject.eng.fl_str_mv |
Azithromycin Spectrophotometry Validation Dissolution |
dc.subject.cnpq.fl_str_mv |
CNPQ::CIENCIAS DA SAUDE::FARMACIA |
description |
Azithromycin (AZ) is a macrolide antibiotic derivate from erytromycin. AZ has a broad spectrum of activity against common gram-negative pathogens and has been used for the treatment of respiratory tract infection, skin infections and sexually transmitted diseases. In the Brazilian market AZ is available as tablets, compounded capsules and powder for oral suspension. The official methods for the assay of AZ in bulk form; capsules and powder for oral suspension are high performance liquid chromatography or microbiological diffusion assay. No monographs are reported in the pharmacopoeias for AZ evaluation in tablets. In this work two spectrophotometric methods were developed and validated for AZ analysis in tablets and powder for oral suspension. The first method was based on the reaction of AZ with concentrated sulfuric acid (98 % w/v), with detection at 226 nm. The other method was based in the charge-transfer reaction of the drug with s-acceptor iodine, with detection at 363 nm. Both methods showed good linearity (r>0.99), precision (CV<5%) and accuracy (>99%). The results obtained with the proposed methods were in good agreement with those obtained by microbiological diffusion agar method. The optimization of dissolution test conditions for in vitro quality control of AZ in tablets was also studied. The use of 900 mL of 0.1N HCl at 37.0 ± 0.5 ºC, paddle as apparatus, at a stirring rate of 50 rpm, provided satisfactory results for tested products. The percent dissolution of AZ in the established condition was more than 90% in 45 minutes. The validated spectrophotometric method used to evaluate the dissolution testing showed to be specific (with no interference of the placebo or tablets in the quantification of AZ), linear (r>0.99), precise (RSD<5%) and accurate (>97%). The drug showed satisfactory stability in the selected dissolution medium |
publishDate |
2007 |
dc.date.accessioned.fl_str_mv |
2007-07-03 |
dc.date.available.fl_str_mv |
2007-07-03 |
dc.date.issued.fl_str_mv |
2007-05-04 |
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 |
FERREIRA, João Ronaldo Notargiacomo. Azithromycin: development and validation of analysis methods in pharmaceutical dosage forms. 2007. 99 f. Dissertação (Mestrado em Farmacologia) - Universidade Federal de Santa Maria, Santa Maria, 2007. |
dc.identifier.uri.fl_str_mv |
http://repositorio.ufsm.br/handle/1/6030 |
identifier_str_mv |
FERREIRA, João Ronaldo Notargiacomo. Azithromycin: development and validation of analysis methods in pharmaceutical dosage forms. 2007. 99 f. Dissertação (Mestrado em Farmacologia) - Universidade Federal de Santa Maria, Santa Maria, 2007. |
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http://repositorio.ufsm.br/handle/1/6030 |
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Universidade Federal de Santa Maria |
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UFSM |
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