Stability indicating for Quality Control Assessment of three antidiabetic molecules using HPLC technique: Stability Assessment of three antidiabetic molecules

Abstract

Diabetes mellitus responds better to co-formulated tablet dosages of dapagliflozin (DFZN), metformin (MFMN), and vildagliptin (VDGN). For the purpose of studying stability and quantifying DFZN, VDGN, and MFMN in bulk forms and in dosage forms, an efficient and fast HPLC method of analysis is currently developed. The mobile phase featured 80:20 (v/v) 0.2 M, pH 3.0, ammonium acetate buffer and acetonitrile mixed together and Luna's HPLC C-18 column, named Phenyl hexyl, was utilised for DFZN, VDGN, and MFMN separation and its quantification. The PDA type detector operating at 235 nm wavelength was deployed. The “International Conference on Harmonisation” recommendations were strictly adhered throughout the validation process. A strong linear association between response and quantity in the range of 2.5–15 µg/ml (DFZN), 25–150 µg/ml (VDGN), and 125–750 µg/ml (MFMN) is supported by the regression information for the DFZN, VDGN, and MFMN calibration plots. The precision, selectivity, accuracy, sensitivity, ruggedness and robustness were satisfactory for the method. The tablet sample of DFZN, VDGN, and MFMN was subjected to acid, water, base, sodium bisulfite, light, dry heat and peroxide degradations. Significant differences in retention times were observed between the well-resolved peaks of the degradants and the primary peaks (DFZN, VDGN, and MFMN). Thus, the assay might be characterised as stability indicating. The contents of DFZN, VDGN, and MFMN in dosage forms were assessed precisely and accurately by currently developed HPLC technique. This technique may be applied to ensure the quality of formulation doses for DFZN, VDGN, and MFMN contents.