High-performance thin-layer chromatographic method for analysis of racecadotril in the bulk drug

A new simple, rapid, reproducible, and stability-indicating high-performance thin-layer chromatographic method for analysis of racecadotril in the bulk drug and in a pharmaceutical formulation has been established and validated. Chromatographic separation was achieved on aluminum-backed silica gel 60F254 HPTLC plates with n -hexane-ethyl acetate 70:30 ( v / v ) as mobile phase. The method gives a compact band for racecadotril ( RF 0.59 ± 0.02) and enables excellent separation of its degradation products. Densitometric analysis of racecadotril was performed in absorbance mode at 230 nm. Linear regression analysis data for the calibration plots were indicative of a good linear relationship between peak area and concentration in the range 200-1600 ng per band (correlation coefficient 0.9975 ± 0.0002); the mean value of the slope and intercept were 2.176 ± 0.0239 and 88.98 ± 2.797, respectively. The method was validated for accuracy, precision, and recovery. The limits of detection and quantification were 50 and 100 ng per band respectively. Racecadotril was subjected to acid and alkaline hydrolysis, and oxidative degradation. The drug undergoes degradation under acidic, basic, and oxidizing conditions. Statistical analysis proves the method enables repeatable, selective, and accurate analysis of racecadotril and can be used for identification and quantification of racecadotril in the bulk drug and in a commercial oral solid dosage form. © Akadémiai Kiadó, Budapest.