[Stability study of ezetimibe in raw material and tablets]

ABSTRACT

Stress conditions were applied on the tested drug [Ezetimibe] according to ICH guidelines. Degradation was found to occur in basic conditions and to much less extent in acidic conditions. The tested compound was stable in light and thermal stress conditions. The analytical validated RP-HPLC method, which has been developed for assaying Ezetimibe previously, is used as stability indicating method. The assay was performed using a C18 column and a mobile phase consist of 50% Acetonitril and 50% buffer [10mm potassium phosphate, pH=2.5 adjusted using phosphoric acid]. The flow rate was 1 ml/min and the analyte was determined using a UV detector at 240 nm. The developed analytical procedure was able to separate the drug from its degradation products, and it was a stability indicating method. Several batches of local manufactured Ezetimibe tablets with different manufacturing dates were assayed. No degradation products were observed in all tested samples, which indicates the stability of Ezetimibe tables in the current conserving conditions