RESUMO
Objective To establish an HPLC method for the determination of metoclopramide (MCP) and its related substances in MCP nasal spray .Methods Chromatographic separation was performed on an Agilent TC-C18 column (250 mm ×4.6 mm,5 μm) using acetonitrile and phosphate buffer solution (0.05 mol/L potassium dihydrogen phosphate solution, added with 5 ml of triethylamine and adjusted to pH 4.0 with phosphoric acid)(19∶81) as the mobile phase at 1.0 ml/min.The detection wavelength was 275 nm and the column temperature was set at 30℃.Results and Conclusion Related substances were completely separated from MCP .For MCP,the linearity of determination was over the range of 10-200 μg/ml and the recovery of the method ranged from 100.3%to 101.6%.The relative standard deviation was 0.68%(n=9).The method is accurate, reliable, repeatable, and could be readily utilized as a quality control method for MSP nasal spray .