Stability indicating validated RP-HPLC technique for the analysis of multicomponent anti-diabetic drug combos in pharmaceutical dosage forms

Abstract

Gliptins represent a dipeptidyl peptidase-4 inhibitors that improve beta cell health and suppress glucagon, leading to improved post-prandial and fasting hyperglycemia used for the treatment of type 2 diabetes mellitus. A simple and quick approach of stability indicating RP-HPLC technique was developed for the determination of Metformin, (Met), Saxagliptin (Saxa) and Sitagliptin (Sita) in bulk and pharmaceutical dosage forms. This projected methodology is apt for the multicomponent estimation of 2 totally different commercially existing combinations in pharmaceutical market used for the treatment of type II diabetes mellitus viz. Sitagliptin and metformin, saxagliptin and metformin in 8 min. A chromatographic separation of the three drugs was attained with a Inertsil C18 (4.6 × 250 mm, 5 μm) analytical column using a buffer potassium dihydrogen phosphate adjusted pH 4 with orthophosphoric acid: methanol:acetonitrile (70:10:20%v/v) in isocratic mode at a flow rate of mL/min, column at ambient temperature and detection of each 3 drugs were monitored at 215 nm using a DAD detector. These established techniques were subjected for forced degradation studies in different stress conditions. This suggested methodology was found to be specific and stability indicating as no interfering peaks of degradation compounds in forced degradation study and excipients was noticed. The Robustness study and percentage of the assay of the formulations was established within the limit of ICH guidelines.