METHOD DEVELOPMENT AND VALIDATION OF VILDAGLIPTIN AND METFORMIN HCl IN PHARMACEUTICAL DOSAGE FORM BY REVERSE PHASE–HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (RP-HPLC)

Determination of the anti-diabetic drugs vildagliptin and metformin is wildly used to validate drug efficiency in diabetic patients. Here we describe a new and simple chromatographic method to analyze both drugs simultaneously in their commercial pharmaceutical dosage forms. A reverse Phase-high performance liquid chromatography (RP-HPLC) separation method was applied using an Xterra C18 column (250 mmL×4.6 mm I.D × 5µ) with acetonitrile: phosphate buffer (pH 6.0): water (65: 20:15v/v/v) as a mobile phase at a flow rate of 1.0 ml/min. Quantification of these drugs by this method was achieved using an ultra violet detector at λ = 239 nm. The limit of detection (LOD) for vildagliptin was 0.0040 µg/ml and 0.025 µg/ml for metformin using this RP-HPLC method. A linear calibration curves were reached at a concentration range of 4-34 µg/ml and 8-54 µg/ml for vildagliptin and metformin, respectively. The developed technique was validated for concentration linearity, robustness, accuracy and precision, and results were statistically analyzed according to the International Conference on Harmonisation (ICH) guidelines. The results presented in this report revealed the development of simple, rapid, precise and accurate RP-HPLC method for immediate determination and validation of vildagliptin and metformin in their pharmaceutical dosage forms.