A fully validated microbiological assay to evaluate the potency of ceftriaxone sodium

Detalhes bibliográficos
Autor(a) principal: Manfio, Maria Luisa
Data de Publicação: 2013
Outros Autores: Agarrayua, Danielle Araújo, Machado, Jaison Carlosso, Schmidt, Cleber Alberto
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da UFBA
Texto Completo: http://repositorio.ufba.br/ri/handle/ri/17131
Resumo: p. 753-762
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spelling Manfio, Maria LuisaAgarrayua, Danielle AraújoMachado, Jaison CarlossoSchmidt, Cleber AlbertoManfio, Maria LuisaAgarrayua, Danielle AraújoMachado, Jaison CarlossoSchmidt, Cleber Alberto2015-03-10T19:26:34Z20131984-8250http://repositorio.ufba.br/ri/handle/ri/17131v. 49, n. 4p. 753-762Ceftriaxone (CFTX) sodium is a third-generation, broad-spectrum cephalosporin that is resistant to beta-lactamases. An alternative bioassay for the assessment of the potency of this drug in pharmaceutical formulations has not been previously reported. Thus, this paper reports the development and full validation of a 3 x 3 agar diffusion bioassay using a cylinder-plate method to quantify CFTX sodium in pharmaceutical samples. The strain Staphylococcus aureus ATCC 6538P was used as the test microorganism, and the results of the proposed bioassay displayed high linearity, precision, accuracy, specificity and robustness. All potency results were statistically analyzed using an analysis of variance (ANOVA) and were found to be linear (r=0.99999) in the range of 16-64 µg/mL, accurate (100.5%), and precise [repeatability: relative standard deviation (RSD)=1.4%; intermediate precision: between-day RSD=2.1% and between-analyst RSD=2.5%]. The specificity of the bioassay was determined by evaluating a degraded sample (50 ºC) at 0, 24 and 48 hours as compared against the results from the pharmacopeial liquid chromatography method for CFTX. The results validated the proposed microbiological assay, which allows reliable quantitation of CFTX in pharmaceutical samples. Moreover, it is a useful, simple and low-cost alternative method for monitoring the quality of this medicine.Submitted by Edileide Reis (leyde-landy@hotmail.com) on 2015-03-10T14:13:31Z No. of bitstreams: 1 Maria Luisa Manfio.pdf: 632033 bytes, checksum: 3981e1aa27f311537b81bfb1cf75e0cc (MD5)Approved for entry into archive by Alda Lima da Silva (sivalda@ufba.br) on 2015-03-10T19:26:34Z (GMT) No. of bitstreams: 1 Maria Luisa Manfio.pdf: 632033 bytes, checksum: 3981e1aa27f311537b81bfb1cf75e0cc (MD5)Made available in DSpace on 2015-03-10T19:26:34Z (GMT). No. of bitstreams: 1 Maria Luisa Manfio.pdf: 632033 bytes, checksum: 3981e1aa27f311537b81bfb1cf75e0cc (MD5) Previous issue date: 2013http://dx.doi.org/10.1590/S1984-82502013000400015reponame:Repositório Institucional da UFBAinstname:Universidade Federal da Bahia (UFBA)instacron:UFBACeftriaxone/agar diffusion assayCeftriaxone/quality controCeftriaxone/microbiological assayDrugs/quality controlA fully validated microbiological assay to evaluate the potency of ceftriaxone sodiumBrazilian Journal of Pharmaceutical Sciencesinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/article10000-01-01info:eu-repo/semantics/openAccessengORIGINALMaria Luisa Manfio.pdfMaria Luisa Manfio.pdfapplication/pdf632033https://repositorio.ufba.br/bitstream/ri/17131/1/Maria%20Luisa%20Manfio.pdf3981e1aa27f311537b81bfb1cf75e0ccMD51LICENSElicense.txtlicense.txttext/plain1345https://repositorio.ufba.br/bitstream/ri/17131/2/license.txtff6eaa8b858ea317fded99f125f5fcd0MD52TEXTMaria Luisa Manfio.pdf.txtMaria Luisa Manfio.pdf.txtExtracted texttext/plain38380https://repositorio.ufba.br/bitstream/ri/17131/3/Maria%20Luisa%20Manfio.pdf.txt2dcf4fefe2d4ac7935579685f4e5d1c9MD53ri/171312022-07-05 14:03:35.117oai:repositorio.ufba.br:ri/17131VGVybW8gZGUgTGljZW7vv71hLCBu77+9byBleGNsdXNpdm8sIHBhcmEgbyBkZXDvv71zaXRvIG5vIFJlcG9zaXTvv71yaW8gSW5zdGl0dWNpb25hbCBkYSBVRkJBLgoKIFBlbG8gcHJvY2Vzc28gZGUgc3VibWlzc++/vW8gZGUgZG9jdW1lbnRvcywgbyBhdXRvciBvdSBzZXUgcmVwcmVzZW50YW50ZSBsZWdhbCwgYW8gYWNlaXRhciAKZXNzZSB0ZXJtbyBkZSBsaWNlbu+/vWEsIGNvbmNlZGUgYW8gUmVwb3NpdO+/vXJpbyBJbnN0aXR1Y2lvbmFsIGRhIFVuaXZlcnNpZGFkZSBGZWRlcmFsIGRhIEJhaGlhIApvIGRpcmVpdG8gZGUgbWFudGVyIHVtYSBj77+9cGlhIGVtIHNldSByZXBvc2l077+9cmlvIGNvbSBhIGZpbmFsaWRhZGUsIHByaW1laXJhLCBkZSBwcmVzZXJ2Ye+/ve+/vW8uIApFc3NlcyB0ZXJtb3MsIG7vv71vIGV4Y2x1c2l2b3MsIG1hbnTvv71tIG9zIGRpcmVpdG9zIGRlIGF1dG9yL2NvcHlyaWdodCwgbWFzIGVudGVuZGUgbyBkb2N1bWVudG8gCmNvbW8gcGFydGUgZG8gYWNlcnZvIGludGVsZWN0dWFsIGRlc3NhIFVuaXZlcnNpZGFkZS4KCiBQYXJhIG9zIGRvY3VtZW50b3MgcHVibGljYWRvcyBjb20gcmVwYXNzZSBkZSBkaXJlaXRvcyBkZSBkaXN0cmlidWnvv73vv71vLCBlc3NlIHRlcm1vIGRlIGxpY2Vu77+9YSAKZW50ZW5kZSBxdWU6CgogTWFudGVuZG8gb3MgZGlyZWl0b3MgYXV0b3JhaXMsIHJlcGFzc2Fkb3MgYSB0ZXJjZWlyb3MsIGVtIGNhc28gZGUgcHVibGljYe+/ve+/vWVzLCBvIHJlcG9zaXTvv71yaW8KcG9kZSByZXN0cmluZ2lyIG8gYWNlc3NvIGFvIHRleHRvIGludGVncmFsLCBtYXMgbGliZXJhIGFzIGluZm9ybWHvv73vv71lcyBzb2JyZSBvIGRvY3VtZW50bwooTWV0YWRhZG9zIGVzY3JpdGl2b3MpLgoKIERlc3RhIGZvcm1hLCBhdGVuZGVuZG8gYW9zIGFuc2Vpb3MgZGVzc2EgdW5pdmVyc2lkYWRlIGVtIG1hbnRlciBzdWEgcHJvZHXvv73vv71vIGNpZW5077+9ZmljYSBjb20gCmFzIHJlc3Ryae+/ve+/vWVzIGltcG9zdGFzIHBlbG9zIGVkaXRvcmVzIGRlIHBlcmnvv71kaWNvcy4KCiBQYXJhIGFzIHB1YmxpY2Hvv73vv71lcyBzZW0gaW5pY2lhdGl2YXMgcXVlIHNlZ3VlbSBhIHBvbO+/vXRpY2EgZGUgQWNlc3NvIEFiZXJ0bywgb3MgZGVw77+9c2l0b3MgCmNvbXB1bHPvv71yaW9zIG5lc3NlIHJlcG9zaXTvv71yaW8gbWFudO+/vW0gb3MgZGlyZWl0b3MgYXV0b3JhaXMsIG1hcyBtYW5077+9bSBhY2Vzc28gaXJyZXN0cml0byAKYW8gbWV0YWRhZG9zIGUgdGV4dG8gY29tcGxldG8uIEFzc2ltLCBhIGFjZWl0Ye+/ve+/vW8gZGVzc2UgdGVybW8gbu+/vW8gbmVjZXNzaXRhIGRlIGNvbnNlbnRpbWVudG8KIHBvciBwYXJ0ZSBkZSBhdXRvcmVzL2RldGVudG9yZXMgZG9zIGRpcmVpdG9zLCBwb3IgZXN0YXJlbSBlbSBpbmljaWF0aXZhcyBkZSBhY2Vzc28gYWJlcnRvLgo=Repositório InstitucionalPUBhttp://192.188.11.11:8080/oai/requestopendoar:19322022-07-05T17:03:35Repositório Institucional da UFBA - Universidade Federal da Bahia (UFBA)false
dc.title.pt_BR.fl_str_mv A fully validated microbiological assay to evaluate the potency of ceftriaxone sodium
dc.title.alternative.pt_BR.fl_str_mv Brazilian Journal of Pharmaceutical Sciences
title A fully validated microbiological assay to evaluate the potency of ceftriaxone sodium
spellingShingle A fully validated microbiological assay to evaluate the potency of ceftriaxone sodium
Manfio, Maria Luisa
Ceftriaxone/agar diffusion assay
Ceftriaxone/quality contro
Ceftriaxone/microbiological assay
Drugs/quality control
title_short A fully validated microbiological assay to evaluate the potency of ceftriaxone sodium
title_full A fully validated microbiological assay to evaluate the potency of ceftriaxone sodium
title_fullStr A fully validated microbiological assay to evaluate the potency of ceftriaxone sodium
title_full_unstemmed A fully validated microbiological assay to evaluate the potency of ceftriaxone sodium
title_sort A fully validated microbiological assay to evaluate the potency of ceftriaxone sodium
author Manfio, Maria Luisa
author_facet Manfio, Maria Luisa
Agarrayua, Danielle Araújo
Machado, Jaison Carlosso
Schmidt, Cleber Alberto
author_role author
author2 Agarrayua, Danielle Araújo
Machado, Jaison Carlosso
Schmidt, Cleber Alberto
author2_role author
author
author
dc.contributor.author.fl_str_mv Manfio, Maria Luisa
Agarrayua, Danielle Araújo
Machado, Jaison Carlosso
Schmidt, Cleber Alberto
Manfio, Maria Luisa
Agarrayua, Danielle Araújo
Machado, Jaison Carlosso
Schmidt, Cleber Alberto
dc.subject.por.fl_str_mv Ceftriaxone/agar diffusion assay
Ceftriaxone/quality contro
Ceftriaxone/microbiological assay
Drugs/quality control
topic Ceftriaxone/agar diffusion assay
Ceftriaxone/quality contro
Ceftriaxone/microbiological assay
Drugs/quality control
description p. 753-762
publishDate 2013
dc.date.issued.fl_str_mv 2013
dc.date.accessioned.fl_str_mv 2015-03-10T19:26:34Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://repositorio.ufba.br/ri/handle/ri/17131
dc.identifier.issn.none.fl_str_mv 1984-8250
dc.identifier.number.pt_BR.fl_str_mv v. 49, n. 4
identifier_str_mv 1984-8250
v. 49, n. 4
url http://repositorio.ufba.br/ri/handle/ri/17131
dc.language.iso.fl_str_mv eng
language eng
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.source.pt_BR.fl_str_mv http://dx.doi.org/10.1590/S1984-82502013000400015
dc.source.none.fl_str_mv reponame:Repositório Institucional da UFBA
instname:Universidade Federal da Bahia (UFBA)
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