Development and validation of dissolution tests for fexofenadine hydrochloride capsules and coated tablets.
OBJECTIVE
This study describes the development and validation of dissolution tests for fexofenadine hydrochloride capsules and coated tablets using an HPLC method.


METHODS
The appropriate conditions were determinate after testing sink conditions, dissolution medium, and agitation intensity. The apparatus, paddle and basket, were applied to tablets and capsules, respectively. Fexofenadine hydrochloride capsules, products A and B, and coated tablets, products A, B and C were evaluated. The best dissolution conditions tested, for the products in each respective pharmaceutical dosage form were applied to evaluate the dissolution profiles. The parameters of difference factor, similar factor, and dissolution efficacy were employed.


RESULTS
Optimal conditions to carry out the dissolution tests were 900 ml of 0.01 M hydrochloric acid as dissolution medium, basket at 100 rotation per minute (rpm) stirring speed for capsules and paddle at 75 rpm for tablets. The dissolution profiles for tablets products A, B, and C and for capsules products A and B were not similar.


CONCLUSIONS
The developed and validated dissolution tests satisfactorily describes the time-course of the drug release. The obtained results provided adequate dissolution profiles. The HPLC method was validated to quantify fexofenadine capsules and coated tablets from the dissolution tests.
Breier
Ana R
AR
Programa de Pós-Graduação em Ciências Farmacêuticas, Faculdade de Farmácia, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, CEP 90610-000, Brazil. anarita_breier@hotmail.com
Paim
Clésio S
CS
Steppe
Martin
M
Schapoval
Elfrides E S
EE
D002214:Capsules; D002626:Chemistry, Pharmaceutical / Q000379:methods; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D012995:Solubility; D013608:Tablets, Enteric-Coated; D016593:Terfenadine / Q000031:analogs & derivatives* / Q000032:analysis / Q000737:chemistry / Q000493:pharmacokinetics
D002214:Capsules; D013608:Tablets, Enteric-Coated; D016593:Terfenadine; C093230:fexofenadine