Development and validation of a stability-indicating HPTLC method for analysis of rupatadine fumarate in the bulk drug and tablet dosage form

Abstract

Summary A simple, selective, precise and stability-indicating high-performance thin-layer chromatographic method for analysis of rupatadine fumarate, both as the bulk drug and in a tablet formulation, has been developed and validated. Aluminium foil TLC plates precoated with silica gel 60F254 were used as stationary phase and toluene-methanol-triethylamine 4:1:0.2 (v/v) as mobile phase. A compact band (RF 0.61 ± 0.02) was obtained for rupatadine fumarate. Densitometric analysis was performed in absorbance mode at 264 nm. Linear regression analysis revealed a good linear relationship (r2 = 0.9992 ± 0.0001) between peak area and concentration in the range 400–1400 ng band−1. The mean values ± SD of the slope and intercept were 2.5471 ± 0.005 and 1055.2 ± 4.20, respectively. The method was validated for precision, recovery, and robustness. The limits of detection and quantitation were 66.63 and 201.91 ng band−1, respectively. Rupatadine fumarate 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 rupatadine fumarate in the bulk drug and in tablet formulations.