Untitled

Abstract

A simple, rapid, accurate, robust, and specific HPLC method was developed for the assay of metformin hydrochloride and teneligliptin hydrobromide from the oral tablet formulations. Stabilityindicating reverse-phase chromatographic method was developed on a RP C18 column (250 mm × 4.6 mm, 5µm) using a mixture of 20 mM ammonium acetate of pH 5.5 and methanol in the ratio 50:50 v/v as mobile phase in an isocratic mode of elution at a flow rate of 1.0 ml/min at 35 ºC with a load of 20 µl. The detection was carried out at 255 nm. The method was validated with respect to linearity, robustness, precision, accuracy, specificity & stability as per ICH guidelines. The method produced excellent separation with good linear correlation coefficients (≥ 0.999) for both the components. The proposed method could be successfully applied for the assay of metformin hydrochloride and teneligliptin hydrobromide from tablet formulations. INTRODUCTION: Metformin hydrochloride is chemically 1,1-Dimethylbiguanide hydrochloride 1 while teneligliptin hydrobromide hydrate is a Dipeptidyl peptidase-4 (DPP-4) inhibitor and chemically it is {(2S,4S)-4-[4-(3-methyl-1-phenyl-1H-pyrazol-5-yl) piperazin-1-yl] pyrrolidin-2-yl} (1,3-thiazolidin-3-yl) methanone hemipentahydrobromide hydrate. Teneligliptin is used in the treatment of type-2 diabetes mellitus 2. The chemical structures of both drugs metformin hydrochloride and teneligliptin hydrobromide are shown in Fig. 1 and Fig. 2, respectively.