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

Abstract

Author(s): Mathrusri Annapurna Mukthinuthalapati* and Bukkapatnam Venkatesh

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-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) 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.

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