Development and validation of a dissolution test for rabeprazole sodium in coated tablets.
The aim of this work is to develop and validate a dissolution test for rabeprazole sodium coated tablets using a reverse-phase liquid chromatographic method. After test sink conditions, dissolution medium and stability of the drug, the best conditions were: paddle at 75 rotations per minute (rpm) stirring speed, HCl 0.1 M and borate buffer pH 9.0 as dissolution medium for acidic and basic steps, respectively, volume of 900 ml for both. The quantitation method was also adapted and validated. Less than 10% of the label amount was released in the acid step, while more than 95% was achieved over 30 min in the basic one. The dissolution profile for tablets was considered satisfactory. The dissolution test developed was adequate for its purpose and could be applied for quality control of rabeprazole tablets, since there is no official monograph.
Garcia
Cassia V
CV
Programa de Pós-Graduação em Ciências Farmacêuticas, Faculdade de Farmácia, Universidade Federal do Rio Grande do Sul., Av. Ipiranga, 2752 Lab. 402, Porto Alegre/RS, CEP 90610-000, Brazil. cassiavgarcia@yahoo.com.br
Paim
Clesio S
CS
Steppe
Martin
M
Schapoval
Elfrides E S
EE
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D001562:Benzimidazoles / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D006863:Hydrogen-Ion Concentration; D009853:Omeprazole / Q000031:analogs & derivatives* / Q000032:analysis; D064750:Rabeprazole; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012995:Solubility; D013056:Spectrophotometry, Ultraviolet; D013607:Tablets / Q000737:chemistry*
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D001562:Benzimidazoles; D013607:Tablets; D064750:Rabeprazole; D009853:Omeprazole