OBJECTIVES: The fixed dose combination of saxagliptin and dapagliflozin is a 
recently approved antidiabetic medication. It is marketed under the brand name 
Qtern. The aim of this study was to develop a simple, rapid, sensitive, and 
validated isocratic reversed phase-high performance liquid chromatography 
(RP-HPLC) method for the simultaneous estimation of saxagliptin and 
dapagliflozin in human plasma using linagliptin as internal standard as per 
US-Food and Drug Administration guidelines.
MATERIALS AND METHODS: The method was performed on a Waters 2695 HPLC equipped 
with a quaternary pump. The analyte separation was achieved using an Eclipse XDB 
C18 (150 × 4.6 mm × 5 µm) column with a mobile phase consisting of 0.1% ortho 
phosphoric acid and acetonitrile (50:50) with pH adjusted to 5.0 at 1 mL/min 
flow rate.
RESULTS: The analyte was detected at 254 nm. The retention time of the internal 
standard, saxagliptin, and dapagliflozin was 2.746, 5.173, and 7.218 min, 
respectively. The peaks were found to be free of interference. The method was 
validated over a dynamic linear range of 0.01 to 0.5 μg/mL and 0.05 to 2 μg/mL 
for saxagliptin and dapagliflozin, respectively, with a correlation coefficient 
of 0.998. The precision and accuracy of samples of six replicate measurements at 
lower limits of quantification level were within the limits. The analytes were 
found to be stable in human plasma at -28°C for 37 days.
CONCLUSION: The stability, sensitivity, specificity, and reproducibility of this 
method make it appropriate for the determination of saxagliptin and 
dapagliflozin in human plasma.