LIQUID CHROMATOGRAPHY-TANDEM MASS SPECTROMETRY ASSAY METHOD FOR ESTIMATION OF SAXAGLIPTINE AND DAPAGLIFLOZIN IN HUMAN PLASMA

Abstract

There has been much research on both saxagliptin and dapagliflozin. However, only a few HPLC and LC-MS methods that use stable labeled isotopes to measure the amount of a drug alone or in combination with other drugs and have a longer chromatographic run time have been published. A quick and sensitive LC-MS/MS mass spectrometric test method has been made and fully validated to find dapagliflozin and saxagliptin in human plasma simultaneously. Solid-phase extraction on the Cleanert PEP-H extraction cartridge was used to separate the analyte and I.S. from the human plasma. The extracted samples were separated on an Ace Phenyl (150 X 4.6 mm, 5 m) column at a set flow rate of 0.8 mL/min using an isocratic mobile phase of acetonitrile and 5 mM ammonium acetate buffer (70:30 v/v). For dapagliflozin, the calibration curve was linear throughout a range of 0.502-227 ng/mL, while for saxagliptin, the range was 0.103-76.402 ng/mL. The procedure was validated in accordance with standards set by the U.S. Food and Drug Administration, and the outcomes are acceptable.