An accurate & precise liquid chromatographic method was developed for the simultaneous estimation of Itopride (ITP) and Metformin (MET) in API matrix. The chromatographic analysis was performed on Shimadzu HPLC equipped with UV-Visible and Diode Array detectors, Column used was Waters XTerra RP C18 column, 5 μm particle size, 250 mm × 4.6 mm i.d, at ambient temperature. The mobile phase consisting of Phosphate Buffer: Methanol (40:60 v/v), and the pH of phosphate buffer was adjusted to 3.5, using Ortho Phosphoric acid (OPA). The flow rate was maintained at 0.8 ml/min and the eluent was monitored at 238 nm. The calibration curves of peak area versus concentration, which was linear from 1-20 μg /mL for ITP and 16-240 μg/mL for MET respectively. The retention times of ITP and MET were found to be 3.47 and 7.34 min respectively. The method had the requisite accuracy, precision and robustness for simultaneous determination of ITP & MET in API matrix. The percentage assays of ITP & MET in API were found out to be 99.27 % and 98.55 % respectively. The method was validated by determining its accuracy, precision and system suitability. The results of the study showed that the proposed RPHPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of ITP & MET in bulk drug and in its pharmaceutical dosage forms.
