Validated Approach of High-performance Liquid Chromatography Method for Degradation Study of Saxagliptin and Metformin HCl

Abstract

Introduction: The study focus on its degradation pattern well know antidiabetic drugs are Saxagliptin and Metformin HCl Aim: The research study aims to validate the high-performance liquid chromatography method for the degradation study of Saxagliptin and Metformin HCl. Method: In support of the determination and to study its degradation pattern in various pharmaceutical dosage forms a novel and simple reverse phase liquid chromatographic method has been established. Saxagliptin and Metformin HCl are well known to use in Type 2 Diabetes. The planned work was performed on Younglin (S.K) isocratic System UV Detector C18 column (150 mm × 4.6 mm). A mixture of Potassium Acetonitrile: Pot. Phosphate Buffer (ph 3.2) in the ratio of 25:75 was used as mobile phase in this method and the method was validated as per ICH guidelines along with flow rate 1.0 ml/min (UV detection at 212 nm) Result: By exposing the drug the Saxagliptin and Metformin HCl to acidic, alkaline, H2O2 and Neutral degradations forced degradation studies were performed. This method (RP-HPLC) is suitable for kinetic studies as well as the assay of pharmaceutical dosage forms and was found to be robust and specific. Conclusion: In any pharmacopoeia, Saxagliptin is not an official drug. While MET was determined by United States Pharmacopeia (USP), and British Pharmacopoeia (BP) both suggest a non-aqueous titration method using anhydrous formic acid as a solvent and 0.1 M perchloric acid as titrant for the assay of MET. An endpoint is determined potentiometrically.