Abstract

ANALYTICAL METHOD DEVELPMENT AND VALIDATION OF ASSAY OF METOCLOPRAMIDE HYDROCHLORIDE API BY USING REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY

P. T. Nilavarasan*, Dr. P. D. Gokulan, Dr. K. L. Senthil Kumar

ABSTRACT

The developed High Performance liquid Chromatography (HPLC) method for the analysis of Development and Validation of assay of Metoclopramide Hydrochloride API is Precise and feasible. The separation was carried out on the Hypersil C18 Column, (length- 250mm x Inner Diameter-4.6 mm), 5.0 μm; using 28:72 of Ammonium acetate Buffer and Acetonitrile as Mobile Phase, with Flow rate 1.0 mL/min, Column temperature-40oC, Sample temperature- 15oC, Wavelength at 210nm, Injection volume is 10 μL, Run time-10 minutes, Diluent-1 is Ethanol and Diluent-2 is Water. Peak shape found satisfactory. System suitability parameter were meets the acceptance criteria and %Relative standard deviation was within the limit. The Correlation coefficient of Linearity for individual solvent, obtained from three replicate injection are not less than 0.998. And all the level of Recoveries are within the limit of 80% to 120%. The method was validated as per International Council for Harmonization (ICH) norms andthe method is also cost effective. The proposed method is useful for rapid analysis of estimation of Assay in Metoclopramide Hydrochloride API.

Keywords: High Performance Liquid Chromatography (HPLC), Metoclopramide Hydrochloride API, UV Detector.