Abstract

DEVELOPMENT AND VALIDATION OF BIOANALYTICAL METHOD FOR SIMULTANEOUS ESTIMATION OF VILDAGLIPTIN AND DAPAGLIFLOZIN DRUGS IN HUMAN PLASMA BY RP-HPLC

Prathmesh Sudhir Gogate* and Shailesh G. Jawarkar

ABSTRACT

A simple, rapid, precise, and accurate Reverse Phase High Performance Liquid (RP-HPLC) Chromatography method was developed for simultaneous determination of Vildagliptin and Dapagliflozin in Human plasma. The method was performed on a Younglin-HPLC system -SP930D The analyte separation was achieved using an Hypersil BDS C18 (250mm x 4.6mm, Particle size: 5µm) column with a mobile phase consisting of (Methanol: Water: Trifluoroacetic acid, (80:20:0.2) with 1.0 ml/min flow rate. UV detection at 219 nm was employed. The retention time for Vildagliptin and Dapagliflozin was 3.10 min and 3.72 min, respectively. The method was validated over a dynamic linear range of 50.0 to 150 μg/mL and 5.0 to 15.0 μg/mL for Vildagliptin and dapagliflozin, respectively, with a correlation coefficient of 0.999. The precision and
accuracy of six replicate measurements at lower quantification levels met the required criteria. The method underwent validation following ICH guidelines, with results falling within acceptable criteria for selectivity, sensitivity, linearity, precision, accuracy, recovery, stability of solution, stability of solution in plasma, and dilution integrity.

Keywords: Vildagliptin, Dapagliflozin, Protein precipitation, Human plasma, RP-HPLC, Simultaneous determination.