Original Articles: 2011 Vol: 3 Issue: 6
A Discriminating UV-Spectrophotometric Method for In-Vitro Dissolution Study of Sertraline Hydrochloride in Tablet Dosage Form
The aim of this work was to develop and validate a dissolution test for Sertraline Hydrochloride in tablets using UV-Spectrophotometric method. The dissolution established conditions were: 900 ml of 0.05M Acetate buffer pH 4.5 as dissolution medium, using a paddle apparatus at a stirring rate of 75 rpm. The drug release was evaluated by UV-Spectrophotometric method at 274 nm. The method was successfully applied to marketed formulations containing 50 mg Sertraline Hydrochloride. More than 90% drug release was achieved in 45 min. in all products. The method was validated to meet requirements for a global regulatory filing. The validation included specificity, linearity, precision and accuracy. The dissolution test developed was adequate for its purpose and could be employed for routine quality control of Sertraline Hydrochloride tablets.