Validated isocratic liquid chromatographic method for the quantification of teneligliptin in the presence of internal standard

Abstract

Introduction: Teneligliptin (TGP) is an oral dipeptidyl peptidase inhibitor used for the treatment of type 2 diabetes mellitus. A simple liquid chromatographic method has been established on isocratic mode for the quantification of TGP in pharmaceutical formulations in the presence of internal standard (IS) eplerenone, and the method was validated. Materials and Methods: Methanol and formic acid mixture was used with a flow rate of 0.4 ml/min (detection at 244 nm) using Agilent column on Shimadzu high-performance liquid chromatography system. Results and Discussion: TGP was eluted at 5.099 min and that of IS at 8.535 min. TGP has shown linearity 1–100 μg/mL with regression equation, y = 95722x–6775.4 correlation coefficient 0.9999. The limit of detection and limit of quantification are found to be 0.2598 μg/mL and 0.8134 μg/mL, respectively. Conclusion: It is observed that this reverse-phase ultra-fast liquid chromatography method is accurate and precise and can be used for the estimation of TGP tablets.