A validated RP-HPLC method for simultaneous determination of Metformin HCl and Vildagliptin in pharmaceutical formulation

Abstract

A selective and sensitive reverse phase high performance liquid chromatographic (RP-HPLC) method has been developed for the separation and quantification of metformin HCl (MET) and vildagliptin (VILD) in tablet dosage form. The determination was carried out using phenomenax C18 column (4.6150 mm) as a stationary phase and mobile phase comprised of phosphate buffer (pH6.0): methanol (65:35v/v). The pH of phosphate buffer is adjusted to 6.0 by using orthophosphoric acid. The flow rate was maintained at 1.0ml/min and the eluent was monitored at 255nm.The retention time of MET and VILD were 1.503 min and 5.530 min respectively. The method was validated in terms of linearity, precision, accuracy, ruggedness, specificity and robustness. The method was linear over the range 50-150 g/ml for both MET (r = 0.999) and VILD (0.998). For precision studies; RSD for MET and VILD were 0.24 and 0.14 respectively. The percentage recoveries for both drugs from their tablets were 100.16 and 99.98 respectively. Inter-day; intra-day RSD for both drugs were found be 0.27 and 0.26, 0.13 and 0.29 respectively.