Simultaneous estimation of dapagliflozin and linagliptin using reverse phase-HPLC with photo diode array (PDA)

Abstract

Dapagliflozin inhibits selective sodium-glucose co-transporter-2 and Linagliptin competitively and reversibly inhibits dipeptidyl peptidase-4 in fixed dose Combination (1:1) is used in the treatment of Type 2 Diabetes Mellitus.For estimation Dapagliflozin and Linagliptin in bulk and Tablet formulation, an accurate and precise method using RP-HPLC was developed and validated.In the method being discussed here was optimized using Hypersil C18 (250 × 4.6 mm, 5 µm) column as Stationary Phase, Mobile Phase being used is Acetonitrile: Water (90:10) adjusting pH 3 using Ammonium Acetate.The Flow Rate was adjusted to 1mL/min.Both Dapagliflozin and Linagliptin (1:1) sample was detected at analytical wavelength of 244nm using Photo diode array detector.The Linearity Range was between Concentration of 0.1µg/mL to 20µg/mL with correlation Coefficient of 0.995 and 0.999 for Dapagliflozin and Linagliptin Respectively.