HPTLC Method for determination of Terbinafine in the Bulk drug and Tablet dosage form

A simple, selective, precise and stability indicating high performance thin layer chromatographic method for analysis of Terbinafine, both as the bulk drug and in a tablet formulation has been developed and validated. In this, method pre coated silica gel 60F 254 aluminum foil TLC plates was used as stationary phase and chromatogram was developed using of n hexane: acetone: glacial acetic acid in the ratio of 8:2:0.1v/v as mobile phase. A compact band with Rf 0.42 was obtained for Terbinafine. Densitometric analysis was performed in absorbance mode at 223nm using Camag TLC scanner. Linear regression analysis revealed a good linear relationship (r =0.9997) between peak area and concentration in the range of 200-1000ng/spot.The method was validated for precision, recovery and robustness. The limit of detection and quantification was 1.204 ng/ spot and 3.648 ng /spot respectively. Terbinafine was subjected to acid, alkaline hydrolysis, oxidative, photochemical and thermal degradation and compound underwent degradation only under photo chemical condition when the standard drug was exposed to UV light. This method under statistical analysis proved a selective, repeatable and accurate analysis of the drug. This method can be used for quantitative analysis of Terbinafine in the bulk drug and in tablet formulation.