STABILITY INDICATING LC-ASSAY METHOD FOR METFORMIN HYDROCHLORIDE AND TENELIGLIPTIN HYDROBROMIDE FROM TABLET FORMULATIONS
AbstractA simple, rapid, accurate, robust, and specific HPLC method was developed for the assay of metformin hydrochloride and teneligliptin hydrobromide from the oral tablet formulations. Stability-indicating 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.
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