DEVELOPMENT AND VALIDATION OF NEW ANALYTICAL METHOD FOR QUANTITATIVE ESTIMATION OF RACECADOTRIL AS AN ACTIVE PHAMACEUTICAL INGREDIENT BY RP-HPLC

A simple and sensitive spectroscopic method was developed for the estimation of Racecadotril in pharmaceutical dosage forms. Spectroscopic method is showing absorbance at 231 nm in methanol. This method obeys Beers law in the concentration range of 8 to100 ig mL -1 respectively. The proposed method is precise, accurate and reproducible and can be extended to the analysis of Racecadotril in bulk and tablet formulations. The quantitative determination of the drug was carried out using the second-derivative values measured at 223, 250 and 273 nm and Third-derivative spectrum values measured at 226and 240nm.Calibration graphs constructed at these wavelengths were linear in the concentration range of 8-100µg mL -1 for secondderivative and third-derivative spectrophotometry method. A HPLC assay utilized Phenomenex-Luna RP-18(2) (250X4.6mm, 5 μm) column, with mobile phase composition of Acetonitrile: 0.05M phosphate buffer (Potassium dihydrogen orthophosphate): triethylamine [80:19.95:0.05, (v/v/v)] of pH 3.953 ± 0.2 was used, and flow rate was 1.0 ml min -1 with UV detection at 231 nm. Atorvastatin calciumvastatin calcium (ATOR) was used as internal standard. The retention time of Racecadotril and ATORVASTATIN CALCIUM were 4.22 and 3.453 min respectively. The total HPLC run time was less than 6 min. Linearity was observed over concentration range of 8-80 µg ml -1 for Racecadotril. The proposed method was validated for various ICH parameters