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

Abstract

Agomelatine is a melatonergic anti-depressant. A stability-indicating high performance liquid chromatographic technique was developed for the determination of Agomelatine in pharmaceutical formulations. Chromatographic separation was achieved on Shimadzu Model CBM-20A/20 Alite, using Zorbax extended-C 18 column (150 mm × 4.6 mm i.d., 5 µm particle size) with a mixture of 0.1% ammonium formate and acetonitrile (40:60, v/v) as mobile phase with a flow rate of 0.8 ml/min. Agomelatine was subjected to stress conditions such as acidic, alkaline, oxidation photolytic and thermal degradations and the method was validated as per ICH guidelines. Key words: Agomelatine, RP-HPLC, Validation, Stability-indicating.