A New Validated Stability Indicating Liquid Chromatographic Method for the Determination of Agomelatine

摘要

Agomelatine is a melatonergic anti-depressant. A stability-indicating highperformance liquid chromatographic technique was developed for thedetermination of Agomelatine in pharmaceutical formulations. Chromatographicseparation was achieved on Shimadzu Model CBM-20A/20 Alite,using Zorbax extended-C18 column (150 × 4.6 mm i.d., 5 μm particle size)with a mixture of 0.1% ammonium formate and acetonitrile (40:60, v/v) asmobile phase with a flow rate of 0.8 ml/min. Agomelatine was subjected tostress conditions such as acidic, alkaline, oxidation photolytic and thermaldegradations and the method was validated as per ICH guidelines.