A validated stability indicating HPTLC method for determination of nitazoxanide

Abstract

A simple, selective, precise and stability-indicating high-performance thin-layer chromatographic (HPTLC) method for nitazoxanide in bulk drug and in formulations was developed and validated. Method employed TLC aluminium plates precoated with silica gel 60F-254 as the stationary phase. Solvent system consisted of ethyl acetate-toluene- methanol (4:6:1, v/v/v). Nitazoxanide was subjected to hydrolysis, oxidation, photolysis and thermal decomposition to establish a validated stability-indicating HPTLC method. Extensive degradation occurred in alkaline medium and in oxidative stress condition and degradation product was well separated from pure drug. Densitometric analysis of nitazoxanide was carried out in absorbance mode at 350 nm. Linear regression analysis data for mean calibration plots showed good linear relationship with r² = 0.9997 in 400-1600 ng per spot. Method was validated with respect to linearity, precision, accuracy, specificity and robustness. The limits of detection and quantitation were 15 and 50 ng per spot, respectively. HPTLC method could effectively separate drug from its degradation product and can be employed as a stability-indicating method.