Stability Indicating HPLC Method for Determination of Racecadotril in Solid Dosage Form

A simple, rapid and accurate RP-HPLC method was developed for the determination of racecadotril in solid pharmaceutical dosage form. The method showed a linear response for concentrations in the range 10-200 μg/ml using methanol: water (80:20 v/v) as the mobile phase with detection at 231 nm and a flow rate of 1.2 ml/min. Solution concentrations were measured at a weight basis to avoid the use of an internal standard. The method was statistically validated for accuracy, precision, linearity, range, ruggedness, robustness, forced degradation, solution stability, and selectivity. Quantitative and recovery studies of the dosage form were also carried out and analyzed; the % RSD from recovery studies was found to be 0.53. Due to the simplicity, rapidity and accuracy of the method, we believe that the method will be useful for routine quality control analysis.