DEVELOPMENT AND VALIDATION OF A DISSOLUTION TEST FOR PRIMAQUINE/POLYETHYLENE OXIDE MATRIX TABLETS

作者：Cruz Ariane P^*; Bertol Charise D; Murakami Fabio S; Pereira Rafael N; Valente Bruno R; Silva Marcos A S; Koester Leticia S

来源：Quimica Nova, 2013, 36(3): 407-412.

• dissolution
• primaquine
• 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 (R-2 > 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.

• 出版日期2013