A NOVEL VALIDATED RP-HPLC METHOD FOR THE DETERMINATION OF ITOPRIDE HYDROCHLORIDE IN BULK AND PHARMACEUTICAL TABLET DOSAGE FORMS

Abstract

A simple, specific, accurate, rapid, inexpensive isocratic Reversed Phase-High Performance Liquid Chromatography (RP-HPLC) method was developed and validated for the quantitative determination of Itopride HCl in pharmaceutical tablet dosage forms. RP-HPLC method was developed by using Welchrom C18Column (4.6 X 250mm, 5µm), Shimadzu LC-20AT Prominence Liquid Chromatograph. The mobile phase composed of 10mM Phosphate buffer (pH-3.0, adjusted with triethylamine): acetonitrile (50:50v/v). The flow rate was set to 1.0 mL.min^-1 with the responses measured at 235nm using Shimadzu SPD-20A Prominence UV-Vis detector. The retention time of Itopride HCl was found to be 2.650 min. Linearity was established for Itopride HCl in the range of 2-10 µg.mL^-1 with correlation coefficient 0.9999. The validation of the developed method was carried out for specificity, linearity, precision, accuracy, robustness, limit of detection, limit of quantitation. The developed method can be used for routine quality control analysis of Itopride HCl in pharmaceutical tablet dosage form.