Stability Indicating Method for Determination of Benznidazole and Its Degradation Products in Active Pharmaceutical Ingredient
Autor(a) principal: | |
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Data de Publicação: | 2020 |
Outros Autores: | , , , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Journal of the Brazilian Chemical Society (Online) |
Texto Completo: | http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0103-50532020000601194 |
Resumo: | Currently, treatment of Chagas disease is restricted to the use of benznidazole and nifurtimox; however, nifurtimox was temporarily suspended in some countries. Based on the limitations in pharmacological treatments, it is essential to guarantee the quality of benznidazole. Therefore, this work aimed to identify the degradation products of benznidazole and to validate a stability indicating method. The stability test was performed through a forced degradation study, exposing benznidazole under a range of conditions. Benznidazole proved to be unstable under acidic and alkaline conditions, and three products were identified by liquid chromatography coupled to a hybrid quadrupole time-of-flight mass spectrometer (UPLC-QTOF-MS). Furthermore, a stability indicating method by high performance liquid chromatography with a diode array detector (HPLC-DAD) for benznidazole was developed and validated according to ICH (International Conference on Harmonisation) and ANVISA (Agência Nacional de Vigilância Sanitária) guidelines. The method was linear (180-420 µg mL-1 range), selective in the presence of degradation products, precise (relative standard deviation (RSD) < 0.6%), accurate (recovery > 99.2%), robust, and free of matrix effects. The method was successfully able to quantify the benznidazole in pharmaceutical formulations. |
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Stability Indicating Method for Determination of Benznidazole and Its Degradation Products in Active Pharmaceutical IngredientbenznidazoleChagas diseasedegradation productsstability indicating methodCurrently, treatment of Chagas disease is restricted to the use of benznidazole and nifurtimox; however, nifurtimox was temporarily suspended in some countries. Based on the limitations in pharmacological treatments, it is essential to guarantee the quality of benznidazole. Therefore, this work aimed to identify the degradation products of benznidazole and to validate a stability indicating method. The stability test was performed through a forced degradation study, exposing benznidazole under a range of conditions. Benznidazole proved to be unstable under acidic and alkaline conditions, and three products were identified by liquid chromatography coupled to a hybrid quadrupole time-of-flight mass spectrometer (UPLC-QTOF-MS). Furthermore, a stability indicating method by high performance liquid chromatography with a diode array detector (HPLC-DAD) for benznidazole was developed and validated according to ICH (International Conference on Harmonisation) and ANVISA (Agência Nacional de Vigilância Sanitária) guidelines. The method was linear (180-420 µg mL-1 range), selective in the presence of degradation products, precise (relative standard deviation (RSD) < 0.6%), accurate (recovery > 99.2%), robust, and free of matrix effects. The method was successfully able to quantify the benznidazole in pharmaceutical formulations.Sociedade Brasileira de Química2020-06-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersiontext/htmlhttp://old.scielo.br/scielo.php?script=sci_arttext&pid=S0103-50532020000601194Journal of the Brazilian Chemical Society v.31 n.6 2020reponame:Journal of the Brazilian Chemical Society (Online)instname:Sociedade Brasileira de Química (SBQ)instacron:SBQ10.21577/0103-5053.20200005info:eu-repo/semantics/openAccessKawaguchi,Wilton H.Fachi,Mariana M.Cerqueira,Leticia B.Campos,Michel L.Gonçalves,Alan G.Trindade,Angela C. L. B.Reason,Iara J. M.Pontarolo,Robertoeng2020-06-04T00:00:00Zoai:scielo:S0103-50532020000601194Revistahttp://jbcs.sbq.org.brONGhttps://old.scielo.br/oai/scielo-oai.php||office@jbcs.sbq.org.br1678-47900103-5053opendoar:2020-06-04T00:00Journal of the Brazilian Chemical Society (Online) - Sociedade Brasileira de Química (SBQ)false |
dc.title.none.fl_str_mv |
Stability Indicating Method for Determination of Benznidazole and Its Degradation Products in Active Pharmaceutical Ingredient |
title |
Stability Indicating Method for Determination of Benznidazole and Its Degradation Products in Active Pharmaceutical Ingredient |
spellingShingle |
Stability Indicating Method for Determination of Benznidazole and Its Degradation Products in Active Pharmaceutical Ingredient Kawaguchi,Wilton H. benznidazole Chagas disease degradation products stability indicating method |
title_short |
Stability Indicating Method for Determination of Benznidazole and Its Degradation Products in Active Pharmaceutical Ingredient |
title_full |
Stability Indicating Method for Determination of Benznidazole and Its Degradation Products in Active Pharmaceutical Ingredient |
title_fullStr |
Stability Indicating Method for Determination of Benznidazole and Its Degradation Products in Active Pharmaceutical Ingredient |
title_full_unstemmed |
Stability Indicating Method for Determination of Benznidazole and Its Degradation Products in Active Pharmaceutical Ingredient |
title_sort |
Stability Indicating Method for Determination of Benznidazole and Its Degradation Products in Active Pharmaceutical Ingredient |
author |
Kawaguchi,Wilton H. |
author_facet |
Kawaguchi,Wilton H. Fachi,Mariana M. Cerqueira,Leticia B. Campos,Michel L. Gonçalves,Alan G. Trindade,Angela C. L. B. Reason,Iara J. M. Pontarolo,Roberto |
author_role |
author |
author2 |
Fachi,Mariana M. Cerqueira,Leticia B. Campos,Michel L. Gonçalves,Alan G. Trindade,Angela C. L. B. Reason,Iara J. M. Pontarolo,Roberto |
author2_role |
author author author author author author author |
dc.contributor.author.fl_str_mv |
Kawaguchi,Wilton H. Fachi,Mariana M. Cerqueira,Leticia B. Campos,Michel L. Gonçalves,Alan G. Trindade,Angela C. L. B. Reason,Iara J. M. Pontarolo,Roberto |
dc.subject.por.fl_str_mv |
benznidazole Chagas disease degradation products stability indicating method |
topic |
benznidazole Chagas disease degradation products stability indicating method |
description |
Currently, treatment of Chagas disease is restricted to the use of benznidazole and nifurtimox; however, nifurtimox was temporarily suspended in some countries. Based on the limitations in pharmacological treatments, it is essential to guarantee the quality of benznidazole. Therefore, this work aimed to identify the degradation products of benznidazole and to validate a stability indicating method. The stability test was performed through a forced degradation study, exposing benznidazole under a range of conditions. Benznidazole proved to be unstable under acidic and alkaline conditions, and three products were identified by liquid chromatography coupled to a hybrid quadrupole time-of-flight mass spectrometer (UPLC-QTOF-MS). Furthermore, a stability indicating method by high performance liquid chromatography with a diode array detector (HPLC-DAD) for benznidazole was developed and validated according to ICH (International Conference on Harmonisation) and ANVISA (Agência Nacional de Vigilância Sanitária) guidelines. The method was linear (180-420 µg mL-1 range), selective in the presence of degradation products, precise (relative standard deviation (RSD) < 0.6%), accurate (recovery > 99.2%), robust, and free of matrix effects. The method was successfully able to quantify the benznidazole in pharmaceutical formulations. |
publishDate |
2020 |
dc.date.none.fl_str_mv |
2020-06-01 |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0103-50532020000601194 |
url |
http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0103-50532020000601194 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
10.21577/0103-5053.20200005 |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
text/html |
dc.publisher.none.fl_str_mv |
Sociedade Brasileira de Química |
publisher.none.fl_str_mv |
Sociedade Brasileira de Química |
dc.source.none.fl_str_mv |
Journal of the Brazilian Chemical Society v.31 n.6 2020 reponame:Journal of the Brazilian Chemical Society (Online) instname:Sociedade Brasileira de Química (SBQ) instacron:SBQ |
instname_str |
Sociedade Brasileira de Química (SBQ) |
instacron_str |
SBQ |
institution |
SBQ |
reponame_str |
Journal of the Brazilian Chemical Society (Online) |
collection |
Journal of the Brazilian Chemical Society (Online) |
repository.name.fl_str_mv |
Journal of the Brazilian Chemical Society (Online) - Sociedade Brasileira de Química (SBQ) |
repository.mail.fl_str_mv |
||office@jbcs.sbq.org.br |
_version_ |
1750318183033602048 |