An International, Peer-Reviewed, Open Access Multidisciplinary Pharmacy Journal

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

Submitted by webadmin on Tue, 10/18/2016 - 17:38
Pharmaceutical Methods,2015,6,3,130-136.
Published:July 2015
Type:Original Article

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

Mathrusri Annapurna Mukthinuthalapati* and Bukkapatnam Venkatesh

Department of Pharmaceutical Analysis & Quality Assurance, GITAM Institute of Pharmacy, GITAM University, Visakhapatnam-530045, INDIA.

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-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.

Chemical structure of Agomelatine (AGM)