Analytical method development and validation for the simultaneous estimation of Metformin and Teneligliptin by RP-HPLC in bulk and tablet dosage forms

An accurate, precise and reproducible high performance liquid chromatographic method was developed for quantitative estimation of Metformin and teneligliptin simultaneously in tablet dosage forms. Younglin (S.K.) gradient System UV Detector and C8 (Agilent) column with 250mm x4.6 mm i.d. and 5ìm particle size. Methanol : water 0.05 % OPA (50:50) was used as the mobile phase for the method. The detection wavelength was 235 nm and flow rate was 0.7 ml/min. In the developed method, the retention time of Metformin and teneligliptin were found to be 2.1 min and 7.6 min. The developed method was validated according to the ICH guidelines. The linearity, precision, range, robustness was within the limits as specified by the ICH guidelines. Hence the method was found to be simple, accurate, precise, economic and reproducible. So the proposed methods can be used for the routine quality control analysis of Metformin and teneligliptin simultaneously in tablet dosage forms.