Development of a Novel RP-HPLC Method for the Simultaneous Quantification of Teneligliptin and Metformin in Pharmaceutical Tablet Formulation

In this work, we devised a practical and efficient RP-HPLC tactic for simultaneously estimating teneligliptin (TEN) and metformin (MET) in both pharmaceutical formulations and bulk substances. Our methodology involved the utilization of a reversed-phase Princeton SPHER-100 C₁₈ column specification (150 × 4.6 mm, 5 μm particle size) as the stationary phase. Briefly, the mobile phase comprised a blend of 0.025 M potassium dihydrogen phosphate (KH₂PO₄) buffer (pH 4) and methanol in a ratio of 40:60, respectively. The recognition of the compounds was conducted at 249 nm wavelength, with a flow rate maintained at 1 mL/min. The developed approach exhibited excellent proportionality across concentration levels of 25-800 μg/mL for MET and 5–60 μg/mL for TEN, with high coefficients of determination (R² = 0.9959 and 0.9958, respectively). Herein, retention times for MET and TEN were determined to be 1.28 and 4.82 minutes, correspondingly. Additionally, recovery rates for MET and TEN ranged from 99.36% to 99.78% and 93.77% to 95.46%, singly. Regarding sensitivity, the limits of detection (LOD) and limits of quantification (LOQ) for TEN were 8.19 µg/mL and 27.30 µg/mL, respectively, while for MET, they were 79.26 µg/mL and 264.20 µg/mL, respectively. The specificity of our tactic was assessed under numerous stress conditions, including exposure to 0.1 M HCl, 0.1 N NaOH, 3% H₂O₂, thermal conditions at 50℃, and UV radiation, demonstrating its robustness.