Author(s): Deepali M. Gangrade, Swati D. Bakshi
The aim of this work was to develop and validate a dissolution test for Betahistine Hydrochloride in controlled release tablet dosage form by using UV visible spectrophotometric method. The dissolution established conditions were: 900 mL of phosphate buffer pH 6.8, using a paddle apparatus at a stirring rate of 100 rpm. The drug release was evaluated by UV visible spectrophotometry method at 260 nm. The method was validated as per the ICH guidelines. The validation included accuracy, precision and linearity. In addition, filter compatibility and drug solution stability in medium were demonstrated.