Stability indicating HPLC determination of racecadotril in bulk drug and pharmaceutical dosage form

A new simple, rapid, reproducible and stability indicating high performance liquid chromatographic method for the analysis of racecadotril in bulk drugs and from pharmaceutical formulation was developed and validated. The HPLC separation was achieved on a BDS -Hypersil C18column (250mm X 4.6mm, i.d. 5μm particle size) using a mobile phase consisting of a mixture of 20 mM phosphate buffer (pH 3.5) and acetonitrile in the ratio of (40:60) at a flow rate of 1 ml/min with detection at 230 nm. The linear regression analysis data for the calibration plots showed good linear relationship with the correlation coefficient of 0.999 with respect to peak area in the concentration range between 5 μg/ml and 15 μg/ml. The method was validated for precision, accuracy, recovery and robustness. The limit of detection and limit of quantitation were found to be 50 and 100 ng/ml respectively. Racecadotril was subjected to acid hydrolysis, alkali hydrolysis and oxidative degradation. The drug undergoes degradation under acidic, basic and oxidation conditions. Statistical analysis proves that the method is repeatable, selective and accurate for the estimation of racecadotril. The proposed developed HPLC method can be applied for identification and estimation of racecadotril in bulk drugs and marketed oral solid dosage forms.