Stability Indicating HPTLC method for Trandolapril Estimation in the Bulk Drug and Tablet Dosage Form

Abstract:

A simple, selective, precise and stability-indicating high-performance thin layer chromatographic method for analysis of , both as the bulk drug and in a tablet formulation, has been developed and validated. Aluminium foil TLC plates precoated with silica gel 60F 254 were used as stationary phase and as mobile phase. A compact band (R_F0.51 ± 0.02 ) was obtained F for . Densitometric analysis was performed in absorbance mode at 220 nm. Linear regression analysis revealed a good linear relationship (r2 =0.9994 ± 0.01 ) between peak area and concentration in the range ng /spot. The mean values ± SD of the slope and intercept were 2.8006 ± 1.23 and 71.67 ± 1.11, respectively. The method was validated for precision, recovery, and robustness. The limits of detection and quantitation were and ng/spot, respectively. was subjected to acid and alkaline hydrolysis, oxidation, and photochemical and thermal degradation and underwent degradation under all these conditions. Statistical analysis proved the method enables repeatable, selective, and accurate analysis of the drug. It can be used for identification and quantitative analysis of in the bulk drug and in tablet formulations.

Key Words: trandolapril, HPTLC, validation, stability-indicating, degradation