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 methods were linear (R²&gt;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.

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Bibliographic Details
Main Authors: Cruz,Ariane P., Bertol,Charise D., Murakami,Fábio S., Pereira,Rafael N., Valente,Bruno R., Silva,Marcos A. S., Koester,Letícia S.
Format: Digital revista
Language:English
Published: Sociedade Brasileira de Química 2013
Online Access:http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0100-40422013000300010
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