Development and validation of a dissolution test for primaquine/polyethylene oxide matrix tablets

Abstract

Recebido em 16/5/12; aceito em 12/10/12; publicado na web em 21/2/13A 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.

Influence of Dissolution Conditions on the Dissolution Rate and Release Mechanism of Ketoprofen From Extended Release Hydrophilic Matrix Systems

“…Out of the several device types described in the USP, apparatus number 1 and 2 are most widely used for oral solid dosage forms [3,7]. According to some authors USP1 is not recommended for dissolution testing of hydrophilic matrix based extended release products because the swelled matrix clogs the orifices of the basket.…”

“…According to some authors USP1 is not recommended for dissolution testing of hydrophilic matrix based extended release products because the swelled matrix clogs the orifices of the basket. Although using a high stirring rate for USP1 allows a better contact compared to the paddle apparatus, due to a higher surface exposed to the media and better hydrodynamics [7].…”

“…The purpose of dissolution testing is found either in the development and optimization of pharmaceutical formulations when a characteristic release profile is wanted or in quality control when the consistency of the product quality is tested across different batches. Dependent on the two main area of applications, a dissolution method should have a discriminating power in quality control in order to identify changes in formulation, raw material attributes and manufacturing that might affect the product's performance [3,7]. However, for the estimation of in vivo performance, the dissolution test should be highly predictive of bioavailability, and not a highly discriminatory power [3].…”