Development and Validated Stability of RP-HPLC Method for Assay of Agomelatine Drug in Tablet Dosage Form
Keywords:
HPLC; Agomelatine, Validation, Stability, Accuracy .Abstract
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.