Journal Article

A Comprehensive Approach to Method Development and Validation for Simultaneous Quantification of Dapagliflozin, Vildagliptin, and Metformin in Tablet Formulation using HPLC

Singh, Bhuvnesh Kumar, Tamta, Neha, Rajpoot, Ashok Kumar, Verma, Harishchandra, Sharma, Nishi, Kumar, Anil, Singh, Nikhil, Trivedi, Neelanchal

2025

Overview

In this work, we present a novel method for determining the prescribed dosages of Dapagliflozin (DAPA), Vildagliptin (VIL), and Metformin (MET) all at once. The goal of this research is to create and test a new RP-HPLC technique that can simultaneously measure DAPA, VIL, and MET in formulation and bulk materials.The goal of this research is to create and test a new RP-HPLC technique that can simultaneously measure DAPA, VIL, and MET in formulation and bulk materials. An isocratic elution method was used with a flow rate of 1.0 ml min-1 and a diode array detector operating at 261nm to perform the chromatographic separation on a kromasil-C18 column(4.5 x 250mm; 5µm). Using orthophosphoric acid to get the pH down to 3.5, the mobile phase consisted of a combination of 0.05 mmol potassium dihydrogen phosphate buffer and acetonitrile in an 80:20 v/v ratio. With concentrations ranging from 0.1-1.0µg/ml and 2-25µg/ml, as well as DAPA, VIL, and MET values from 10 to 120µg/ml, the calibration curve displayed linearity. The research found that DAPA had a limit of detection and quantification of 0.0122µg/ml while VIL had a limit of 0.0323µg/ml. The upper limits for MET were 0.232µg/ml and 0.635µg/ml, while the lower limits were 1.124µg/ml and 3.124µg/ml, respectively. We have developed and validated a new reversed-phase high-performance liquid chromatography (RP-HPLC) method for the quantitative determination of vildagliptin and metformin. This method is very sensitive, easy to use, and stable. The suggested technique could be used to routinely measure DAPA, VIL, and MET.