Development and Validation of a Stability-Indicating HPTLC Method for Analysis of Bumetanide in the Bulk Drug and Tablet Dosage Form

A simple, selective, precise and stability-indicating high-performance thin layer chromatographic method for analysis of bumetanide (BUM), 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: ethyl acetate: formic acid (7: 3.5: 0.5, v/v/v) as mobile phase. A compact band (RF 0.45 ± 0.02) was obtained for BUM. Densitometric analysis was performed in absorbance mode at 335 nm. Linear regression analysis revealed a good linear relationship (r2 = 0.9996) between peak area and concentration in the range 100–800 ng/spot. The mean values ± RSD of the slope and intercept were 0.9987 ± 0.965 and 23.471 ± 1.24, respectively. The method was validated for precision, recovery, and robustness. The limits of detection and quantitation were 30 and 80 ng/spot, respectively. BUM 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 BUM in the bulk drug and in tablet formulations.