Development and Validation of UV Spectrophotometric and Stability Indicating RP-HPLC Assay Method for Agomelatine in Bulk and Pharmaceutical Formulations

Abstract

Agomelatine is a novel anti-depressant drug. The aim of the present work was to develop and validate an accurate, simple, rapid and cost effective UVVisible specrophotometric and stability indicating RP-HPLC method for estimation of Agomelatine in bulk and in pharmaceutical dosage form. In UVVisible spectrophotometric method estimation of Agomelatine was done on its λmax 230nm using water: ACN (50:50) as a solvent. The calibration curve was found linear in the range of 0.5 – 4.0 μg/ml for Agomelatine (R2= 0.9999). A sensitive stability indicating RP-HPLC method was developed with ZORBAX Eclipse XDB C18 column (150 mm x 4.6mm x 5μm) with optimized mobile phase containing Buffer (pH 3.0): ACN: TEA (62:38:0.1 %v/v/v). Detection of Agomelatine was carried out at 230nm. The linearity for Agomelatine was found in the range of 10 – 40 μg/mL (R2= 0.9999). Other parameters for the developed methods were validated according to the ICH guidelines. High percentage recovery shows that there is no interference of excipients in the dosage form. Both the methods were applied on pharmaceutical dosage form. The proposed UV-Visible Spectrophotometric method was accurate, precise, sensitive and cost-effective that can be successfully applied to bulk drugs and pharmaceutical formulation. The stability indicating RP-HPLC assay method was also simple, accurate, precise and specific and has the ability to separate the drug Agomelatine, its degradation products.