Application of Validated HPLC Method for Degradation Study of Vildagliptin and Metformin HCl

Abstract

A novel and simple reverse phase liquid chromatographic method has been established for the determination of Sitagliptin and Metformin HCl and studies its degradation pattern in pharmaceutical dosage forms. Sitagliptin and Metformin HCl is used to control Type 2 Diabetes. The proposed work was performed on Younglin( S.K) isocratic System UV DetectorC18 column (150 mm 4.6 mm). A mixture of Potassium Phosphate buffer pH-3.2 with orthophosphoric acid and acetonitrile was used as mobile phase in this method with flow rate 0.7 ml/min (UV detection at 203 nm) and the method was validated as per ICH guidelines. Forced degradation studies were performed by exposing the drug Sitagliptin and Metformin HCl to acidic, alkaline, oxidation and thermal stress degradations. The proposed RP-HPLC method was found to be robust and specific and this method is suitable for the assay of pharmaceutical dosage forms as well as kinetic studies.