Development and validation of method for simultaneous estimation of Triple Drug Combination Employed for Type II Diabetes Mellitus and its validation using ICH Q2R1

ABSTRACT

This study reports the method development and validation for anti-diabetic drugs by UPLC.  A new, simple, rapid, selective, precise and accurate ultra performance liquid chromatography assay has been developed for simultaneous estimation of Remogliflozin, Vildagliptin and Metformin. The separation was achieved by using ODS 3V column with dimensions 5 µm, 4.6 mm x 250 mm. The pH of mobile phase was adjusted to 4.5 with acetonitrile. The flow rate was 0.4 mL/min, and the separated drugs were detected using UPLC detector at the wavelength of 260 nm. The method was validated as per ICH guidelines. The proposed method was found to be accurate, reproducible, and consistent. It was successfully applied for the analysis of these drugs in marketed formulations and could be effectively used for the routine analysis of formulations.

Keywords: Remogliflozin, Vildagliptin, Metformin, ICH guidelines