ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF THREE COMBINATION DRUGS REMOGLIFLOZIN ETABONATE, METFORMINE AND VILDAGLIPTIN BY RP-HPLC TECHNIQUEAbstract
Remogliflozin Etabonate, Metformin, Vildagliptin are anti-diabetic drugs. It inhibits the sodium-glucose transport proteins (SGLT), which are responsible – for glucose reabsorption in the kidney. Blocking this transporter causes blood glucose to be eliminated through the urine. Several attempts were made on simultaneous analysis of Metformin with either Vildagliptin or Remogliflozin but no work were carried out on simultaneous analysis of all three drugs combination. In the present work, efforts are made to develop a simple new accurate, precise and linear reverse phase high performance liquid Chromatographic (RP-HPLC) method for simultaneous estimation of Remogliflozin etabonate (RGE), Metformin (MET) and Vildagliptin (VGN) in bulk drug and marketed tablet formulation Different analytical performance parameters such as linearity, precision, accuracy, specificity, limit of detection (LOD) and limit of quantification (LOQ) were determined according to International Conference on Harmonization ICH Q2B guidelines. Chromatographic separation was achieved on Acclaimed Mix Mode HILIC-1 column (150 mm × 4.6 mm, 5µm) applying an isocratic elution based on 20 mM ammonium acetate: acetonitrile (75:25, v/v) as a mobile phase. The ultraviolet detector was operated at 230 and 254 nm. The retention time for RGE was 3.81+0.5min, VGN was 4.86+0.5min, MET was 5.81+0.5min. The standard curve was linear over the concentration range of 3.9-62.5µg/ml with r2 close to one (1 to 0.999). The proposed method was validated for system suitability, specificity, linearity, accuracy, precision, LOD, LOQ and robustness. All parameters were found to be within the acceptance limit.
Tabassum Bano *, Madhuri Channawar and A. V. Chandewar
P. Wadhwani College of Pharmacy, Dhamangaon Road Yavatmal, Maharashtra, India.
05 April 2023
05 June 2023
09 June 2023
01 November 2023