A NOVEL STABILITY-INDICATING REVERSE PHASE LIQUID CHROMATOGRAPHIC METHOD FOR THE SIMULTANEOUS ESTIMATION OF METFORMIN AND TENELIGLIPTIN IN PURE AND PHARMACEUTICAL FORMULATIONS

Abstract

Objective: The present method was proposed to develop a simple, sensitive, rapid, accurate and stability-indicating reverse phase liquid chromatographic method for the simultaneous estimation of metformin and teneligliptin in pure and pharmaceutical formulations. Methods: The chromatographic separation was done on Discovery [250 mm X 4.6 mm: 5 μm is particle size] using a mobile phase composed of 0.1% orthophosphoric acid buffer: acetonitrile [65:35, v/v], the flow rate is 1 ml/min and the detection was carried out at 260 nm.Results: The retention time of metformin and teneligliptin were found to be 2.517 min and 3.687 min, respectively. Stability indicating studies were conducting under the guidelines of an international conference on harmonization [ICH] Q1A R2 and the developed method was validated as per guidelines of ICH Q2 RI. The linearity was found in the range of concentration of 125-750 μg/ml and 5-30 μg/ml for metformin and teneligliptin. The detection of limit and quantification of limit was found to be 0.02 μg/ml and 0.07 μg/ml for metformin and 0.19 μg/ml and 0.56 μg/ml for teneligliptin, respectively.Conclusion: A novel stability-indicating reverse-phase liquid chromatographic method for the simultaneous estimation of metformin and teneligliptin. The proposed method was adopted for the routine estimation of metformin and teneligliptin in bulk and pharmaceutical dosage forms.