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

Imran A Sheikh, Manoj S. Charde, Rita D. Chakole


A novel and simple reverse phase liquid chromatographic method has been established for the determination of Vildagliptin and Metformin HCl and studies its degradation pattern in pharmaceutical dosage forms. Vildagliptin and Metformin HCl is used to control Type 2 Diabetes. The proposed work was performed on Younglin (S.K) isocratic System UV Detector C18 column (150 mm × 4.6 mm). A mixture of Potassium Phosphate, 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 Vildagliptin 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.


Vildagliptin, Metformin HCl, RP-HPLC, validation, stability-indicating

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