BIOANALYTICAL METHOD FOR THE ESTIMATION OF ZIFTOMENIB AND ITS APPLICATION TO PHARMACOKINETIC STUDIES USING LC-MS/MS

Objectives: Food and Drug Administration (FDA) approved and menin inhibitor category drug of ziftomenib was used in the treatment of acute myeloid leukemia. For the bioanalytical approach of ziftomenib, a quick and easy, exact, active, and repeatable liquid chromatography-tandem mass spectrometry methodology was created, employing revumenib as an internal standard. Methods: In this study, a symmetry C18 column (150 mm × 4.6 mm, 3.5 μm) was used for separation. Buffer (1 ml per chloric acid in 1 lt of water) and acetonitrile (60:40% v/v) as the mobile phase combination with 1 mL/min flow rate at room temperature. Results: The calibration curve was linear in the range of 5–200 ng/mL of ziftomenib with r2 = 0.9997. Matrix effect, accuracy, and precision results were within the acceptable limits according to the United States FDA (USFDA) requirements, we found that the drugs were stable throughout the stability trials. The validated method had effectively performed the drug’s pharmacokinetic investigations. Conclusion: The application denotes that all the parameters of system suitability, specificity, linearity, and accuracy are in good agreement with USFDA guidelines and applied effectively for the investigation of pharmacokinetic studies in rats.