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

A sim ple, specific , accurate , rapid , inexpensive isocratic Reversed Phase - High Performance Liquid Chromatography (RP - HPLC) method was developed and validated for the quantitative determin ation of Itopride HCl in pharmaceutical tablet dosage forms . RP - HPLC method was developed by using Welchrom C 18 Column (4.6 X 250mm, 5µm), Shimadzu LC - 20AT Prominence Liquid C hromatograph. The mobile phase composed of 10mM P hosphate buffer (pH - 3.0, adjusted with triethylamine) : acetonitrile ( 50:50 v/v ) . The flow rate was set to 1.0 mL . min - 1 with the responses measured at 2 35 nm using Shimadzu SPD - 20A Prominence UV - V is detector. The retention time of Itopride HCl was found to be 2.650 min. Linearity was established for Itopride HC l in the range of 2 - 10 µg.mL - 1 with correlation coefficient 0.999 9 . The validation of the developed method was carried out for specificity, linearity, precision, accuracy, robustness, limit of detection, limit of quanti t ation. The developed method can be used for routine quality control analysis of Itopride