Isocratic RP-UHPLC method development and validation of stability-indicating for simultaneous determination of teneligliptin and metformin in fixed-dose combination

Abstract

The pharmaceutical combination of Teneligliptin Hydrobromide hydrate (TEN) and Metformin Hydrochloride (MET) drugs is used in the treatment of type 2 diabetes mellitus. A new analytical method: QuEChERS (Quick, Easy, Cheap, Effective, Rugged, Safe) has been developed for the quantification of Teneligliptin (TEN) and Metformin (MET) in bulk and tablet dosage forms. The analysis was performed on Agilent symmetry analytical column Eclipse plus C18 (150 mm × 4.6 mm, 5 μm) ultra- performance liquid chromatography-Diode Array Detectors (UHPLCDAD), while the detection was performed on 233 nm using Diode Array Detectors. Buffer and acetonitrile (65:35 v/v) were the mobile phase, run at a flow rate of 0.7 mL min−1 for isocratic elution. The buffer used in the mobile phase contained 50 mM potassium di-hydrogen phosphate, pH adjusted to 3.5±0.02 with orthophosphoric acid. The mean values of recovery were found to be 100.50% and 99.81%. The proposed method could be ideal for quantitative evaluation in pharmaceutical preparations of these drugs and also for their quality control in bulk manufacturing. Stress test covers: acid, base, peroxide, thermal and photolytic degradation; were conducted to show the specificity of the method and degradation.