Stability Indicating Assay Method Development and Validation of Sitagliptin and Metformin Combination Tablets by Reverse Phase-HPLC

Abstract

Two pharmaceutical compounds were isolated, separated, and confirmed using chromatographic techniques. The method involved utilizing an inertsil phenyl analytical the analytical column has dimensions of 250 mm x 4.0 mm and contains particles with a size of 5 µm. A solution is filled as a buffer, combined with a mobile phase containing a grid. with a pH of 4.0 made from potassium dihydrogen phosphate, orthophosphoric acid and of acetonitrile in a 70:30 ratio 0.8 mL per minute. The column temperature is maintained at 30℃ as part of the setup. The detection of the two drugs is continuously monitored using this setup. A wavelength of 210 nm using a UV detector with injection volume 20 µL. Forced degradation studies are carried out using PDA detector. Peak homogeneity explained as peak purity using lab solution software.