Estimation of Sitagliptin and Metformin by Using RP-HPLC

Abstract

The present study focuses on the development and validation of a simple, precise, and accurate Reverse Phase High-Performance Liquid Chromatographic (RP-HPLC) method for the simultaneous estimation of Sitagliptin and Metformin in bulk and pharmaceutical dosage forms. Chromatographic separation was achieved using a Waters HPLC system equipped with an autosampler and PDA detector (model 996), and an Altima C18 column (4.6 × 150 mm, 5 µm) maintained at 35°C. The mobile phase consisted of Methanol and Acetonitrile in a 50:50 (v/v/v) ratio, delivered at a flow rate of 1.0 mL/min. Detection was performed at 260 nm with an injection volume of 10 µL and a total run time of 14 minutes. The method was validated as per ICH guidelines, demonstrating excellent linearity, precision, accuracy, specificity, and sensitivity for both Sitagliptin and Metformin. The method was successfully applied for the analysis of commercial tablet formulations without interference from excipients. This validated RP-HPLC method is suitable for routine quality control and analysis of Sitagliptin and Metformin in pharmaceutical preparations.