Microbiological assay for quantitative determination of Imipenem in powder for injection
Autor(a) principal: | |
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Data de Publicação: | 2018 |
Outros Autores: | , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Institucional da UFRGS |
Texto Completo: | http://hdl.handle.net/10183/195925 |
Resumo: | This work describes the development and validation of a microbiological method using the cylinder-plate assay for quantitative determination of imipenem in powder for injection. The aim was to obtain a low-cost and suitable methodology that can be alternative to physicochemical techniques already described, contributing for the quality control of this antibiotic. Firstly, the analytical conditions were optimized, testing the microorganism, inoculum concentration and best range of sample and standard concentrations, in a way that provides the adequate measurement of the inhibition halos. Staphylococcus epidermidis ATCC 12228 was selected as test microorganism, as well as 2.0 % of inoculum concentration. The validation protocol followed the official guidelines, and the parameters evaluated were linearity, precision (intermediate precision and repeatability) and accuracy. All standard curves ranging 0.5-2.0 μg/mL showed r values higher than 0.999, and ANOVA confirmed that were no deviation from linearity (p-value > 0.05). The method also proved to be precise with RSD (relative standard deviation) values ranging 0.28-0.64 for repeatability and 2.49 for intermediate precision. It was performed three days of experiments, being three assays of eight plates a day. The drug mean content was 101.05%. Accuracy was assessed by recovery test, with standard recovery percentage of 101.70-107.90% (mean recovery = 104.86%), which was considered satisfactory. Therefore, the proposed microbiological method was considered validated and suitable for application in quantitative determination of this drug, being useful for quality control routine. |
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Oliveira, Sendy SalesBarbosa, Fábio de SouzaPezzi, Leonardo CapraSchapoval, Elfrides Eva SchermanMendez, Andreas Sebastian Loureiro2019-06-19T02:34:15Z20182527-2616http://hdl.handle.net/10183/195925001089786This work describes the development and validation of a microbiological method using the cylinder-plate assay for quantitative determination of imipenem in powder for injection. The aim was to obtain a low-cost and suitable methodology that can be alternative to physicochemical techniques already described, contributing for the quality control of this antibiotic. Firstly, the analytical conditions were optimized, testing the microorganism, inoculum concentration and best range of sample and standard concentrations, in a way that provides the adequate measurement of the inhibition halos. Staphylococcus epidermidis ATCC 12228 was selected as test microorganism, as well as 2.0 % of inoculum concentration. The validation protocol followed the official guidelines, and the parameters evaluated were linearity, precision (intermediate precision and repeatability) and accuracy. All standard curves ranging 0.5-2.0 μg/mL showed r values higher than 0.999, and ANOVA confirmed that were no deviation from linearity (p-value > 0.05). The method also proved to be precise with RSD (relative standard deviation) values ranging 0.28-0.64 for repeatability and 2.49 for intermediate precision. It was performed three days of experiments, being three assays of eight plates a day. The drug mean content was 101.05%. Accuracy was assessed by recovery test, with standard recovery percentage of 101.70-107.90% (mean recovery = 104.86%), which was considered satisfactory. Therefore, the proposed microbiological method was considered validated and suitable for application in quantitative determination of this drug, being useful for quality control routine.application/pdfengDrug Analytical Research. Porto Alegre, RS. Vol. 2, no. 2 (2018), p. 8-13Controle de qualidadeImipenemImipenemMicrobiological assayQuantitative determinationValidationQuality controlMicrobiological assay for quantitative determination of Imipenem in powder for injectioninfo:eu-repo/semantics/articleinfo:eu-repo/semantics/otherinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da UFRGSinstname:Universidade Federal do Rio Grande do Sul (UFRGS)instacron:UFRGSTEXT001089786.pdf.txt001089786.pdf.txtExtracted Texttext/plain25395http://www.lume.ufrgs.br/bitstream/10183/195925/2/001089786.pdf.txt779f31811a08c31a996bd7423ea6bdf4MD52ORIGINAL001089786.pdfTexto completo (inglês)application/pdf230425http://www.lume.ufrgs.br/bitstream/10183/195925/1/001089786.pdf05970b8df609d34b07e8836ea059bdb4MD5110183/1959252021-05-07 05:09:38.167548oai:www.lume.ufrgs.br:10183/195925Repositório de PublicaçõesPUBhttps://lume.ufrgs.br/oai/requestopendoar:2021-05-07T08:09:38Repositório Institucional da UFRGS - Universidade Federal do Rio Grande do Sul (UFRGS)false |
dc.title.pt_BR.fl_str_mv |
Microbiological assay for quantitative determination of Imipenem in powder for injection |
title |
Microbiological assay for quantitative determination of Imipenem in powder for injection |
spellingShingle |
Microbiological assay for quantitative determination of Imipenem in powder for injection Oliveira, Sendy Sales Controle de qualidade Imipenem Imipenem Microbiological assay Quantitative determination Validation Quality control |
title_short |
Microbiological assay for quantitative determination of Imipenem in powder for injection |
title_full |
Microbiological assay for quantitative determination of Imipenem in powder for injection |
title_fullStr |
Microbiological assay for quantitative determination of Imipenem in powder for injection |
title_full_unstemmed |
Microbiological assay for quantitative determination of Imipenem in powder for injection |
title_sort |
Microbiological assay for quantitative determination of Imipenem in powder for injection |
author |
Oliveira, Sendy Sales |
author_facet |
Oliveira, Sendy Sales Barbosa, Fábio de Souza Pezzi, Leonardo Capra Schapoval, Elfrides Eva Scherman Mendez, Andreas Sebastian Loureiro |
author_role |
author |
author2 |
Barbosa, Fábio de Souza Pezzi, Leonardo Capra Schapoval, Elfrides Eva Scherman Mendez, Andreas Sebastian Loureiro |
author2_role |
author author author author |
dc.contributor.author.fl_str_mv |
Oliveira, Sendy Sales Barbosa, Fábio de Souza Pezzi, Leonardo Capra Schapoval, Elfrides Eva Scherman Mendez, Andreas Sebastian Loureiro |
dc.subject.por.fl_str_mv |
Controle de qualidade Imipenem |
topic |
Controle de qualidade Imipenem Imipenem Microbiological assay Quantitative determination Validation Quality control |
dc.subject.eng.fl_str_mv |
Imipenem Microbiological assay Quantitative determination Validation Quality control |
description |
This work describes the development and validation of a microbiological method using the cylinder-plate assay for quantitative determination of imipenem in powder for injection. The aim was to obtain a low-cost and suitable methodology that can be alternative to physicochemical techniques already described, contributing for the quality control of this antibiotic. Firstly, the analytical conditions were optimized, testing the microorganism, inoculum concentration and best range of sample and standard concentrations, in a way that provides the adequate measurement of the inhibition halos. Staphylococcus epidermidis ATCC 12228 was selected as test microorganism, as well as 2.0 % of inoculum concentration. The validation protocol followed the official guidelines, and the parameters evaluated were linearity, precision (intermediate precision and repeatability) and accuracy. All standard curves ranging 0.5-2.0 μg/mL showed r values higher than 0.999, and ANOVA confirmed that were no deviation from linearity (p-value > 0.05). The method also proved to be precise with RSD (relative standard deviation) values ranging 0.28-0.64 for repeatability and 2.49 for intermediate precision. It was performed three days of experiments, being three assays of eight plates a day. The drug mean content was 101.05%. Accuracy was assessed by recovery test, with standard recovery percentage of 101.70-107.90% (mean recovery = 104.86%), which was considered satisfactory. Therefore, the proposed microbiological method was considered validated and suitable for application in quantitative determination of this drug, being useful for quality control routine. |
publishDate |
2018 |
dc.date.issued.fl_str_mv |
2018 |
dc.date.accessioned.fl_str_mv |
2019-06-19T02:34:15Z |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/other |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://hdl.handle.net/10183/195925 |
dc.identifier.issn.pt_BR.fl_str_mv |
2527-2616 |
dc.identifier.nrb.pt_BR.fl_str_mv |
001089786 |
identifier_str_mv |
2527-2616 001089786 |
url |
http://hdl.handle.net/10183/195925 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.ispartof.pt_BR.fl_str_mv |
Drug Analytical Research. Porto Alegre, RS. Vol. 2, no. 2 (2018), p. 8-13 |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
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application/pdf |
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reponame:Repositório Institucional da UFRGS instname:Universidade Federal do Rio Grande do Sul (UFRGS) instacron:UFRGS |
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UFRGS |
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Repositório Institucional da UFRGS |
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Repositório Institucional da UFRGS |
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http://www.lume.ufrgs.br/bitstream/10183/195925/2/001089786.pdf.txt http://www.lume.ufrgs.br/bitstream/10183/195925/1/001089786.pdf |
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