Method Development and Validation for simultaneous Quantification of Remogliflozin and Metformin in Bulk and Tablets by RP-HPLC

Abstract

In this study, a novel technique was developed and validated for the simultaneous estimation of Remogliflozin (REMO) and Metformin (MET) in bulk and formulation. The separation was achieved using ODS, C18 (250mm × 4.6mm, i.d.2.5µm) column with isocratic elution. A mixture of acetonitrile: 20 mM ammonium formate buffer (pH 3.5) at the ratio of (60:40) as mobile phase with a flow rate of 1.0ml min-1 was used for the separation of analytes. The separated effluents were monitored with diode array detector at 243nm. The results showed good linearity over a range of 2.5–25μg ml-1 and 12.5–125μg ml-1 for REMO and MET respectively. Furthermore, the average percentage assay of marketed formulations of REMO and MET was found to be 100.30% and 100.52%, respectively. REMO limit of detection (LOD) and limit of quantitation (LOQ) were 0.42 and 1.28μg ml-1 while LOD and LOQ for MET were 1.97 and 5.96μg ml-1 respectively. The proposed method was simple, rapid and precise for the study of new formulations which has been approved for the cure of diabetes mellitus and applicable for the analysis of both drugs in pharmaceutical industries effectively.