DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR ANALYSIS OF RACECADOTRIL IN PURE AND FORMULATIONS

Abstract

A rapid, simple and validated reversed-phase high-performance liquid chromatographic method has been developed for analysis of Racecadotril in Tablet dosage form. Racecadotril was separated on a Phenomenex C18 column (250 mm length, 4.6 mm internal diameter and particle size 5 μm) with a 60:40 (v/v) mixture of Acetonitrile and Phosphate buffer as mobile phase at a flow rate of 1.0 mL min-1. The effluent was monitored by UV detection at 228 nm. Calibration plots were linear in the range of 10 to 50 μg mL-1 and the LOD and LOQ were 0.635 and 1.94 μg mL-1, respectively. The high recovery and low relative standard deviation values confirm the suitability of the method for routine quality control determination of Racecadotril in tablets.