Validated RP-HPLC method development for the simultaneous estimation of antidiabetic drugs

Abstract

A force degradation profile of Metformin HCL & Glimepiride in combine tablet dosage form on RP-HPLC was developed using Grace RP-C18 (4.6 x 150 mm, 5 µm) in an gradient mode with mobile phase comprising  of Acetonitrile: Dihydrogen Pott.Phosphate (pH 2.5 using 0.1% OPA) The flow rate was 0.7 mL/ min and effluent was monitored at 242 nm.. The retention times were found to be 2.06 min for MET and 5.80 min for GLIM. The assay shows a linear dynamic range of 250.0- 1250.0 µg/mL for MET and 1.0-5.0 µg/mL for GLIM. The calibration curves were linear (r² = 0.999 for MET and r² = 0.998 for GLIM) over the entire linear range. Mean % recovery was found to be 99.80 % for MET and 98.93 % for  GLIM  with % RSD was NMT 2.0 for both estimations which fully agrees with system suitability which is in good agreement with labeled amount of formulation. The % RSD for Intra- Day & Inter-Day Precision was NMT than 2.0 for both the drugs. The developed method was validated as per ICH guidelines.