Development and validation of a dissolution test for primaquine/polyethylene oxide matrix tablets
dc.contributor.author | Cruz, Ariane Pinheiro | pt_BR |
dc.contributor.author | Bertol, Charise Dallazem | pt_BR |
dc.contributor.author | Murakami, Fábio Seigi | pt_BR |
dc.contributor.author | Pereira, Rafael Noschang | pt_BR |
dc.contributor.author | Valente, Bruno R. | pt_BR |
dc.contributor.author | Silva, Marcos Antônio Segatto da | pt_BR |
dc.contributor.author | Koester, Leticia Scherer | pt_BR |
dc.date.accessioned | 2014-03-01T01:54:22Z | pt_BR |
dc.date.issued | 2013 | pt_BR |
dc.identifier.issn | 0100-4042 | pt_BR |
dc.identifier.uri | http://hdl.handle.net/10183/88060 | pt_BR |
dc.description.abstract | A simple, precise, specific, repeatable and discriminating dissolution test for primaquine (PQ) matrix tablets was developed and validated according to ICH and FDA guidelines. Two UV assaying methods were validated for determination of PQ released in 0.1 M hydrochloric acid and water media. Both methods were linear (R2>0.999), precise (R.S.D.<1.87%) and accurate (97.65-99.97%). Dissolution efficiency (69-88%) and equivalence of formulations (f2) was assessed in different media and apparatuses (basket/100 rpm and paddle/50 rpm) tested. Discriminating condition was 900 mL aqueous medium, basket at 100 rpm and sampling times at 1, 4 and 8 h. Repeatability (R.S.D.<2.71%) and intermediate precision (R.S.D.<2.06%) of dissolution method were satisfactory. | en |
dc.format.mimetype | application/pdf | |
dc.language.iso | por | pt_BR |
dc.relation.ispartof | Química nova. São Paulo: Sociedade Brasileira de Química, 1978-. Vol. 36, n. 3, (2013), p. 407-412 | pt_BR |
dc.rights | Open Access | en |
dc.subject | Dissolução | pt_BR |
dc.subject | dissolution | en |
dc.subject | Primaquina | pt_BR |
dc.subject | primaquine | en |
dc.subject | matrix tablets | en |
dc.subject | Óxido de polietileno | pt_BR |
dc.subject | Validação : Métodos de análise de fármacos | pt_BR |
dc.title | Development and validation of a dissolution test for primaquine/polyethylene oxide matrix tablets | pt_BR |
dc.type | Artigo de periódico | pt_BR |
dc.identifier.nrb | 000897683 | pt_BR |
dc.type.origin | Nacional | pt_BR |
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