Rapid RP-HPLC Quantification and Stress Degradation Studies on Alogliptin, Saxagliptin, Metformin in Pharmaceutical Dosage Formulation

Abstract

A Fast and simple isocratic method of stability indicating RP-HPLC technique was established for determination of Alogliptin, Saxagliptin and Metformin in pharmaceutical dosage forms. The proposed method is suitable for multicomponent analysis of commercially existing combinations in market. An LC separation of these drugs were achieved with Inertsil ODS C18 (4.6 x 250mm, 5mm) using potassium dihydrogen phosphate adjusted to pH 3: acetonitrile (85:15%V/V) in isocratic mode at 1mL min-1, at ambient temperature and detection at 280 nm. These drugs were exposed to forced degradation studies in altered stress conditions. The proposed method was found to be precise, stability indicating as no interfering peaks were noticed. Robustness studies and assay of the dosage forms were established within the limit of ICH guidelines.