Simultaneous Estimation of Itopride and Gliclazide Potassium by HPLC In API Matrix

An accurate & precise liquid chromatographic method was developed for the simultaneous estimation of Itopride (ITP) and Gliclazide (GCZ) in API matrix. The chromatographic analysis was performed on GRACE C18 [250 x 4.6 mm i.d, 5 µ particle size) with mobile phase consisting of 0.05M Potassium Dihydrogen phosphate and 0.5% Tri Ethyl Amine (TEA) buffer having pH 2.7 and Methanol in the ratio of 60:40 v/v at a flow rate of 0.8 mL/ min and UV detection was carried out at 238 nm. The calibration curves of peak area versus concentration, which was linear from 10 - 100 µg/mL for ITP and 5 – 50 µg/mL for GCZ respectively. The retention times of ITP and GCZ were 2.951 and 7.735 min respectively. The method had the requisite accuracy, precision and robustness for simultaneous determination of ITP & GCZ in API matrix. The percentage assays of ITP & GCZ were found out to be 100.80% and 99.76% respectively. The method was validated by determining its accuracy, precision and system suitability. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of ITP & GCZ in bulk drug and in its pharmaceutical dosage forms.