BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTIFICATION OF TRAZODONE IN HUMAN PLASMA BY HPLC-MS/MS

Hariprakash Kandasamy*, Anbarasi Balakrishnan, Vijayamitharaj Ramaswamy, Senthilkumar Natesan, Kathiravan Natarasan

ABSTRACT

Objective: The development and validation of bioanalytical process approach for assessing the antidepressant medication Traz in human plasma is the ultimate goal of the current investigation. Methods: The method involves tandem-mass spectroscopy combined with HPLC SPE technique bioanalytic method development and validation conducted for the first time. Using Aceton-M: 5 mM ammonium formate buffer (90:10% V/V), at 1.00 mL/min flow rate, with 10μl of injection volume, allowed for excellent separation and elimination. This chromatographic analysis analyte and IS were started under isocratic conditions to develop an easier separation technique in a shorter run time. Report: According to the method, the range of calibration curve is from 25.2640-352.3060 ng/ml. By using numerous supporting data points, including batch recovery percentages of 85.0433% and 82.3800% over TRAZ and TRAZD6, a technique validation has been established. Conclusion: The simple, highly accurate, precise, sturdy, reproducible and reliable HPLC-MS/MS technique was formed that proves all the stability parameters and is suitable for the bioequivalence study in the future. This method may also be applicable for the combined formulations.

Keywords: Trazodone, LC-MS/MS, Trazodone D6, LLOQ, USFDA.