High-performance thin-layer chromatographic analysis of bicalutamide in bulk drug and liposomes

A sensitive, accurate, precise, and specific high-performance thin-layer chromatographic (HPTLC) method for analysis of bicalutamide in the bulk drug and in a liposomal formulation containing cholesterol and lecithin and other surfactants has been established and validated in accordance with ICH guidelines. HPTLC on aluminum foil-backed silica gel 60F-254 plates with toluene-ethyl acetate 4.5:5.5 ( v / v ) as mobile phase gave compact bands for bicalutamide ( RF 0.45). Leflunomide ( RF 0.85) was used as internal standard. Densitometric analysis of bicalutamide was performed in absorbance mode at 273 nm. The method was validated for accuracy, precision, linearity, robustness, and limits of detection and quantitation. The method is specific, selective, and free from matrix interferences at the RF of bicalutamide and the internal standard. Regression data for the calibration plots were indicative of a good linear relationship (correlation coefficient 0.9994 ± 0.002) between response and amount of bicalutamide in the concentration range 200-1600 ng per band. The limits of detection and quantitation were 50 and 200 ng per band, respectively. © Akadémiai Kiadó, Budapest.