ANALYTICAL METHOD DEVELOPMENT AND VALIDATION AND STABILITY STUDIES OF THE ESTIMATION OF AGOMELATINE IN TABLET DOSAGE FORM BY RP-HPLC
Journal Title: Int J of Preclin & Pharm Res - Year 2014, Vol 4, Issue 6
Abstract
ABSTRACT Agomelatine is a new melatonergic antidepressant with a unique pharmacological action. A stability indicating RP-HPLC method was developed and validated for the determination of agomelatine in active pharmaceutical ingredient using enable thermo hypersil C18 column (250×4.6mm, 5μm) in isocratic mode. The mobile phase consisted of phosphate buffer: methanol (60:40, v/v) with a flow rate of 1.0 ml/min (PDA detection- 232nm).The Retention time was found to be 3.3 min. Linearity was observed over the concentration range of 25 μg/ml to 75μg/ml and the correlation coefficient R2value was found to be 0.999. The method is accurate and recovery was found to be in the range of 98.91-99.18%. The limit of detection of agomelatine was found to be 2.8μg/ml and limit of quantitation was found to be 9.4μg/ml. Agomelatine was subjected to stress conditions including acidic, alkaline, oxidation, photolysis and thermal degradation. Agomelatine is more sensitive to heat and oxidative degradation. The method was validated according to ICH guidelines. Keywords: Agomelatine, HPLC method, Validation, Stability-indicating.
Authors and Affiliations
Vineela P*, Pavani B, Ajitha A, Uma Maheshwara Rao. V
Keywords
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