Development and Validation of a Stability-Indicating RP-HPLC Method for Analysis of Racecadotril in Pharmaceutical Dosage Forms

A simple stability-indicating RP-HPLC method has been developed and validated for the determination of Racecadotril (RAC) in pharmaceutical dosage forms. The mobile phase consisting of methanol and tetra butyl ammonium hydrogen sulphate (80: 20, v/v) was used using isocratic elution with UV detection at 230 nm. The method showed good linearity for RAC in the 5-120 μg/mL range being the square of the correlation coefficient greater than 0.999. The limit of quantitation (LOQ) and limit of detection (LOD) were found to be 0.87527 and 0.28884 μg/mL respectively. The robustness was also evaluated by variations of mobile phase composition, flow rate and detection wavelength. The forced degradation kinetic study of Racecadotril by using HCl (0.1 M), NaOH (0.01 M), H2O2 (3%v/v), thermal (80±2 °C), hydrolysis and UV radiation (365 nm) were observed to be very specific. Finally the applicability of the method was evaluated in commercial dosage form analysis as well as in stability studies.