Determination of racecadotril by HPLC in capsules

A simple, precise and rapid RP-HPLC method was developed for the determination of racecadotril in a pharmaceutical formulation using gemfibrozil as internal standard. Ratio of the peak area of analyte to internal standard was used for quantification. The chromatographic separation was carried out by using a Reverse Phase C18 column (BDS-Hypersil). The mobile phase consisting of a mixture of 20 mM phosphate buffer (pH 3.5) and acetonitrile in the ratio of (40:60) with detection at 230 nm at a flow rate of 1 ml/min was employed. The method was statistically validated for linearity, accuracy and precision. The elution time was 6.9 min for racecadotril and 9.8 min for gemfibrozil. The simplicity and accuracy of the proposed method ensures its use in routine quality control analysis of pharmaceutical formulations.