Reverse-Phase Liquid Chromatography Method Development and Validation for Simultaneous Estimation of Drugs:...

A precise, fast and efficient technique utilizing reverse-phase liquid chromatography was established for the simultaneous estimation of Remogliflozin, Metformin and Vildagliptin, in a commercial pharmaceutical preparation. The method utilized a HiQ Sil C18 analytical column having a size of 250 × 4.6 mm and particle size utilized was 5 μm. The mobile phase composition comprised a mixture of potassium dihydrogen orthophosphate buffer (pH 4.7), methanol and acetonitrile in a ratio of 20:55:25 v/v/v. The flow rate was adjusted to 1.2 mL/min. Three UV wavelengths were finalized for Remogliflozin (276 nm), Metformin (227 nm) and Vildagliptin (213 nm), but the detection wavelength utilized for HPLC was 210 nm (isosbestic point). After validation, it was observed that the method exhibited linearity, as evidenced by correlation coefficients of 0.9994, 0.9997 and 0.9980 for Remogliflozin, Metformin and Vildagliptin, respectively. The recovery values for the three compounds were found 103.42%, 100.39% and 99.97%. Additionally, the relative standard deviation for six replicates consistently remained below 2%. This HPLC method was effectively employed for the quantitative analysis of the target drugs in tablet formulations.