ABSTRACT

Reversed phase high performance liquid chromatography (RP-HPLC) method for the quantitative determination of saxagliptin (SXG) in human urine was developed and validated to support clinical studies. Chromatographic separation was achieved on an Inertsil® column (250 mm x 4.6 mm, 5 µm). Isocratic elution using a mobile phase of potassium dihydrogen phosphate buffer pH (3) - acetonitrile (80:20, V/V) at a flow rate of 1 mL min-1 with UV detection at 212.1 nm was performed. The retention time of saxagliptin was 6.4 min. The method was validated according to United State Food and Drug Administration (USFDA) (May-2001) guidelines. The developed bioanalytical method was found to be selective, accurate, precise, and having good extraction efficiency. The developed method was satisfactorily applied to the routine quality control analysis of the saxagliptin.