Concurrent Estimation of a Three Combination Type-2 Anti-diabetic Oral Dosage Form by Ultra-performance Liquid Chromatography

Abstract

Estimation of a three-combination dosage form containing metformin (MET), vildagliptin (VLDG), and remogliflozin etabonate (REMET) was performed by developing an economically simple and isocratic simultaneous method using ultra-performance liquid chromatograph (Alliance 1100 series) comprising of X-Bridge (50 × 4.6 mm, 2.5 μ) C18 column and photo diode array detector. 0.1 % v/v trifluoro acetic acid: acetonitrile (60:40% v/v) movable phase at 0.5 mL/min was used. The analytes were detected at a wavelength of 240.0 nm at 8.0 min. run time. The respective retention times of 1.004, 2.005, 5.118 min. was achieved concurrently for metformin, vildagliptin, and remogliflozin etabonate. The method was validated for various parameters according to international council for harmonization. Linearity was established at 187.50 to 1125.00 μg/mL (R2 = 0.9997), 18.75 to 112.50 μg/mL (R2 = 0.9990), 37.50 - 225.00 μg/ mL (R2 = 0.9997). The respective limit of detection and quantification were 22.50; 75.0 (MET) 2.25; 7.5 (VLDG) and 4.50; 15.0 μg/mL (REM ET). A recovery (% w/w) of 99.0 ± 1 % was obtained for metformin, vildagliptin, and remogliflozin etabonate, respectively. Various degradation studies were conducted and degradants were identified at different retention times.