Development and Validated Stability of RP-HPLC Method for Assay of Agomelatine Drug in Tablet Dosage Form
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Publication date: 2019-05-23
Eurasian J Anal Chem 2019;14(2):emEJAC191038
A simple, efficient, and precise stability indicating RP-HPLC method has been developed and validated to measure Agomelatine at wavelength (230 nm) in order to assay. Agomelatine is used to treat Depression. Methanol was used as a solvent with λmax of drug was found to be 230 nm. The samples were eluted in an isocratic method using Water symmetry (C18, 5um, 4.6nm×250mm) with a mobile phase consisting of pH 5.0 Buffer Dipotassium Hydrogen Phosphate: ACN (50:50) using as diluents through ambient temperature delivered at a flow rate 1.2mL/min. Linearity was observed in the range of 20-120μg/ml with a regression coefficient of 0.99. Stability of analytical solution was carried out at different time interval 0, 24, 36 and 48hr. The stress testing of the drugs was carried out under acidic, alkaline, photo-stability, neutral, oxidation and dry heat conditions. The method was quantitatively evaluated in terms of accuracy (recovery), linearity, precision, selectivity and robustness in accordance with standard ICH validation guidelines. The method is simple and suitable for analyzing Agomelatine in bulk and in pharmaceutical formulations.