Forced Degradation Studies of Agomelatine:Development and Validation of Stability Indicating RP-HPLC Method using Internal Standard

Agomelatine is an anti-depressent drug. A new simple stability indicating reverse phase liquid chromatographic method has been established for the determination of Agomelatine in presence of an internal standard. Agomelatine is used for the treatment of prostate cancer. The proposed work has been performed on Shimadzu Model CBM-20A/20 Alite with Phenomenex C18 column (250 mm × 4.6 mm i.d., 5 μm particle size) using 0.1% formic acid and acetonitrile mixture as the mobile phase with flow rate 0.6 ml/min (UV detection at 205 nm). The method was validated as per ICH guidelines and the regression equation was found to be y = 0.2084x - 0.0475. Agomelatine was subjected to acidic, alkaline, oxidation, UV and thermal stress degradations and the method was reported to be robust and specific and can be applied for the assay of pharmaceutical formulations.