Abstract

STABILITY-INDICATING HPTLC METHOD FOR QUANTITATIVE ESTIMATION OF AGOMELATINE IN BULK AND PHARMACEUTICAL DOSAGE FORM

Joshi Hitendra S. *, Rupareliya Reema H.

ABSTRACT

A simple, precise and stability-indicating high performance thin chromatographic method for analysis of Agomelatine in bulk drug and in a tablet formulation has been developed and validated. Aluminum foil TLC plates pre-coated with silica gel 60F were used as stationary phase Dichloro methane and methanol in the ratio of (95:5v/v) were used as mobile phase. A compact band (Rf 0.52±0.002) was obtained for Agomelatine. Densitometric analysis was performed in absorbance mode at 230 nm. Linear regression analysis revealed a good linear relationship (r2= 0.9982) between peak area and concentration in the range of 0.2-0.8 μg/spot. The precision (relative standard deviation: RSD) among a six sample preparation was 0.94% and 0.93%. The accuracy (recovery) was validated for specificity, linearity, precision, recovery and robustness. The limits of detection and quantization were also determined. Statistical analysis proved the method enables repeatable, selective and accurate for analysis of the drug. It can be used for identification and quantitative analysis of Agomelatine in bulk drug and in tablet formulation.

Keywords: Agomelatine, Stability-Indicating, Method Validation, HPTLC Method.