Development and validation of a dissolution test for primaquine/polyethylene oxide matrix tablets
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 met...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Sociedade Brasileira de Química
2013-01-01
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| Series: | Química Nova |
| Subjects: | |
| Online Access: | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0100-40422013000300010 |
| _version_ | 1819133705251192832 |
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| author | Ariane P. Cruz Charise D. Bertol Fábio S. Murakami Rafael N. Pereira Bruno R. Valente Marcos A. S. Silva Letícia S. Koester |
| author_facet | Ariane P. Cruz Charise D. Bertol Fábio S. Murakami Rafael N. Pereira Bruno R. Valente Marcos A. S. Silva Letícia S. Koester |
| author_sort | Ariane P. Cruz |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-22T09:51:32Z |
| format | Article |
| id | doaj.art-b3da04766e134dbeb5b7b794d683e4a7 |
| institution | Directory Open Access Journal |
| issn | 0100-4042 1678-7064 |
| language | English |
| last_indexed | 2024-12-22T09:51:32Z |
| publishDate | 2013-01-01 |
| publisher | Sociedade Brasileira de Química |
| record_format | Article |
| series | Química Nova |
| spelling | doaj.art-b3da04766e134dbeb5b7b794d683e4a72022-12-21T18:30:22ZengSociedade Brasileira de QuímicaQuímica Nova0100-40421678-70642013-01-01363407412Development and validation of a dissolution test for primaquine/polyethylene oxide matrix tabletsAriane P. CruzCharise D. BertolFábio S. MurakamiRafael N. PereiraBruno R. ValenteMarcos A. S. SilvaLetícia S. KoesterA 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.http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0100-40422013000300010dissolutionprimaquinematrix tablets |
| spellingShingle | Ariane P. Cruz Charise D. Bertol Fábio S. Murakami Rafael N. Pereira Bruno R. Valente Marcos A. S. Silva Letícia S. Koester Development and validation of a dissolution test for primaquine/polyethylene oxide matrix tablets Química Nova dissolution primaquine matrix tablets |
| title | Development and validation of a dissolution test for primaquine/polyethylene oxide matrix tablets |
| title_full | Development and validation of a dissolution test for primaquine/polyethylene oxide matrix tablets |
| title_fullStr | Development and validation of a dissolution test for primaquine/polyethylene oxide matrix tablets |
| title_full_unstemmed | Development and validation of a dissolution test for primaquine/polyethylene oxide matrix tablets |
| title_short | Development and validation of a dissolution test for primaquine/polyethylene oxide matrix tablets |
| title_sort | development and validation of a dissolution test for primaquine polyethylene oxide matrix tablets |
| topic | dissolution primaquine matrix tablets |
| url | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0100-40422013000300010 |
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