Assessing Drug-Excipient Interactions in the Formulation of Isoniazid Tablets
Autor(a) principal: | |
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Data de Publicação: | 2016 |
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=S0103-50532016000500826 |
Resumo: | A suitable and efficient high-performance liquid chromatography (HPLC) method was developed for the simultaneous determination of tuberculostatic isoniazid and its related impurities, isonicotinic acid and isonicotinamide, in oral solid dosage forms. We studied the influence on chromatographic separation of mobile phase parameters, such as pH, ion pairing and ionic strength, as well as column bonded phase and brands. The use of buffer solution pH 6.8:acetonitrile 96:4 (v/v) at 0.8 mL min-1, C18 column (250 × 4.6 mm, 5 µm), allowed proper separation of these ionizable analytes without the need of ion pairing agents. The limit of quantification of the method (0.1 µg mL-1) was suitable for the analysis of impurities. A drug-excipient compatibility study was carried out with the anaytical method proposed in this work and addressed frequent excipients used in isoniazid coated tablets. The dye FD&C blue 2 lake promoted the highest degradation of the tuberculostatic agent. |
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Assessing Drug-Excipient Interactions in the Formulation of Isoniazid TabletstuberculosisisoniazidHPLCdrug-excipient compatibilityA suitable and efficient high-performance liquid chromatography (HPLC) method was developed for the simultaneous determination of tuberculostatic isoniazid and its related impurities, isonicotinic acid and isonicotinamide, in oral solid dosage forms. We studied the influence on chromatographic separation of mobile phase parameters, such as pH, ion pairing and ionic strength, as well as column bonded phase and brands. The use of buffer solution pH 6.8:acetonitrile 96:4 (v/v) at 0.8 mL min-1, C18 column (250 × 4.6 mm, 5 µm), allowed proper separation of these ionizable analytes without the need of ion pairing agents. The limit of quantification of the method (0.1 µg mL-1) was suitable for the analysis of impurities. A drug-excipient compatibility study was carried out with the anaytical method proposed in this work and addressed frequent excipients used in isoniazid coated tablets. The dye FD&C blue 2 lake promoted the highest degradation of the tuberculostatic agent.Sociedade Brasileira de Química2016-05-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersiontext/htmlhttp://old.scielo.br/scielo.php?script=sci_arttext&pid=S0103-50532016000500826Journal of the Brazilian Chemical Society v.27 n.5 2016reponame:Journal of the Brazilian Chemical Society (Online)instname:Sociedade Brasileira de Química (SBQ)instacron:SBQ10.5935/0103-5053.20150334info:eu-repo/semantics/openAccessWollinger,WagnerSilva,Raphael A. daNóbrega,Andréa B. daLopes,Rosangela S. C.Lopes,Claudio C.Slana,Glaucia B. C. A.eng2016-05-18T00:00:00Zoai:scielo:S0103-50532016000500826Revistahttp://jbcs.sbq.org.brONGhttps://old.scielo.br/oai/scielo-oai.php||office@jbcs.sbq.org.br1678-47900103-5053opendoar:2016-05-18T00:00Journal of the Brazilian Chemical Society (Online) - Sociedade Brasileira de Química (SBQ)false |
dc.title.none.fl_str_mv |
Assessing Drug-Excipient Interactions in the Formulation of Isoniazid Tablets |
title |
Assessing Drug-Excipient Interactions in the Formulation of Isoniazid Tablets |
spellingShingle |
Assessing Drug-Excipient Interactions in the Formulation of Isoniazid Tablets Wollinger,Wagner tuberculosis isoniazid HPLC drug-excipient compatibility |
title_short |
Assessing Drug-Excipient Interactions in the Formulation of Isoniazid Tablets |
title_full |
Assessing Drug-Excipient Interactions in the Formulation of Isoniazid Tablets |
title_fullStr |
Assessing Drug-Excipient Interactions in the Formulation of Isoniazid Tablets |
title_full_unstemmed |
Assessing Drug-Excipient Interactions in the Formulation of Isoniazid Tablets |
title_sort |
Assessing Drug-Excipient Interactions in the Formulation of Isoniazid Tablets |
author |
Wollinger,Wagner |
author_facet |
Wollinger,Wagner Silva,Raphael A. da Nóbrega,Andréa B. da Lopes,Rosangela S. C. Lopes,Claudio C. Slana,Glaucia B. C. A. |
author_role |
author |
author2 |
Silva,Raphael A. da Nóbrega,Andréa B. da Lopes,Rosangela S. C. Lopes,Claudio C. Slana,Glaucia B. C. A. |
author2_role |
author author author author author |
dc.contributor.author.fl_str_mv |
Wollinger,Wagner Silva,Raphael A. da Nóbrega,Andréa B. da Lopes,Rosangela S. C. Lopes,Claudio C. Slana,Glaucia B. C. A. |
dc.subject.por.fl_str_mv |
tuberculosis isoniazid HPLC drug-excipient compatibility |
topic |
tuberculosis isoniazid HPLC drug-excipient compatibility |
description |
A suitable and efficient high-performance liquid chromatography (HPLC) method was developed for the simultaneous determination of tuberculostatic isoniazid and its related impurities, isonicotinic acid and isonicotinamide, in oral solid dosage forms. We studied the influence on chromatographic separation of mobile phase parameters, such as pH, ion pairing and ionic strength, as well as column bonded phase and brands. The use of buffer solution pH 6.8:acetonitrile 96:4 (v/v) at 0.8 mL min-1, C18 column (250 × 4.6 mm, 5 µm), allowed proper separation of these ionizable analytes without the need of ion pairing agents. The limit of quantification of the method (0.1 µg mL-1) was suitable for the analysis of impurities. A drug-excipient compatibility study was carried out with the anaytical method proposed in this work and addressed frequent excipients used in isoniazid coated tablets. The dye FD&C blue 2 lake promoted the highest degradation of the tuberculostatic agent. |
publishDate |
2016 |
dc.date.none.fl_str_mv |
2016-05-01 |
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=S0103-50532016000500826 |
url |
http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0103-50532016000500826 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
10.5935/0103-5053.20150334 |
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.27 n.5 2016 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_ |
1750318178313961472 |