Development and Validation of Fast and Sensitive RP-HPLC Stability Indicating Method for Quantification of Teneligliptin in Bulk Drug.

Teneligliptin (TEN) is a novel, third-generation DPP4 inhibitor (Dipeptidyl peptidase) used for the treatment of Type 2 Diabetes Mellitus. A rapid, simple and highly sensitive stability-indicating reverse-phase high-performance liquid chromatographic technique coupled with a photodiode array detector was developed and validated for the estimation of TEN. The λ max was determined at 246 nm. The mobile phase comprised Methanol: Water (containing 1% perchloric acid):Triethylamine (80:20:1) at room temperature with a flow rate of 1 mL min−1. The chromatographic separation was achieved with Inertsil C-18 Octadecyl-silica (ODS) (250 × 4.6 mm), 5 μm column with a retention time of 2.6 min (min). The developed method is fast with a run time of 6 min and sensitive with LOD 35 ng mL−1 that was never reported earlier. The calibration curve was found to be linear in the range of 1–32 μg mL−1 with a R2 value of 0.990. The developed method is validated as per International Conference on Harmonization guidelines. TEN was evaluated under stress conditions that included hydrolytic (acid, alkali and neutral), oxidative and thermal degradation. Significant degradation was observed in basic, oxidative and thermal degradation conditions. The developed method was employed successfully to estimate the amount of TEN in bulk and pharmaceutical formulation. [ABSTRACT FROM AUTHOR]