Optimization and Validation of HPLC Method for Simultaneous Determination of Vildagliptin, Pioglitazone Hydrochloride and Glimepiride in Bulk and Tablets

Abstract

A new isocratic HPLC method is optimized and validated for simultaneous determination of Vildagliptin (VLD), Pioglitazone Hydrochloride (PIO) and Glimepiride (GLIM) in Bulk and tablets (Gliptus ® and Amaglust ® tablets). The chromatographic separation was achieved on a reversed-phase analytical column [Hypersilgold ® C18 (10µm, 150 x 4.6 mm) column] at ambient temperature. The separation was achieved by applying an isocratic elution system using acetonitrile and 0.05M potassium dihydrogen phosphate buffer, adjusted by orthophosphoric acid to a pH of 3.5 with a ratio of (45:55 v/v) respectively, at a flow rate of 1.5 ml/min. The UV detection was performed at 200 nm, the drugs calibration curves exhibited linear concentration ranges of 5-75, 3-45 and 1-8 µg/ml for Vildagliptin, Pioglitazone and Glimepiride respectively with correlation coefficients not less than 0.9996.