An Efficient Method For Simultaneous Estimation Of Alogliptin And Metformin In Pharmaceutical Dosage Form By Using Rp-Hplc

Abstract

Combining alogliptin with metformin is a common way to treat type 2 diabetes patients with high blood sugar. This study's primary goal was to establish an assay that was rapid, accurate, and precise as well as a rapid reversed-phase high performance liquid chromatographic (RP-HPLC) approach that could simultaneously estimate both metformin and alogliptin from a combination drug product. The suggested procedure involves separating the two drugs in reversed-phase mode using a Water C18 250 4.6 mm, 5 column that is kept at room temperature. Acetonitrile: Ammonium Phosphate buffer pH 3.5 (70:30 v/v) was the ideal mobile phase mixture, with a flow rate of 1.0 mL/min, and VWD detection at 214 nm. ICH guidelines were followed in the method's validation. With correlation values of 0.998 and 0.999, respectively, Alogliptin and Metformin showed linearity in the concentration ranges of 6.25-18.75 g/mL and 250-750 g/mL. With an RSD of less than 2.0%, the mean percent recovery of triplicate samples at each level for both medicines was determined to be between 98 and 100 percent. For metformin and alogliptin, the standard calibration curve was established in the concentration range of 500 g/mL and 12.5 g/mL, respectively. Metformin's percent of label claim was determined to be 100.48 and alogliptin's to be 100.11. The established HPLC method's validation is linear, accurate, precise, particular, and robust. It is a time- and cost-saving technique with several uses in quantification, routine analysis, forced degradation research, stability investigations, and other fields.