METHOD DEVELOPMENT AND VALIDATION OF BALOXAVIR MARBOXIL BY LCMS

Abstract

Objective: The goal of this work was to create a validated LC-MS/MS method for measuring baloxavir Marboxil
Methods: Using a Phenomenex C18 HPLC column (50 mm 4.6 mm, 5 m, 100), the chromatographic separation was
achieved with 0.1 percent formic acid in combination with methanol (30:70 v/v), which offered the best peak shape
and minimum baseline noise. The flow rate was set at 0.3 ml/min and the entire analytical time was 3 minutes.
Results: The method presented in this paper was developed and verified in human plasma at concentrations ranging
from 5.0 to10000.00 pg/ml. The intra-batch precision (% CV) was less than 6.0 percent, and the percent accuracy
ranged from 94.08 percent to 98.4 percent. For Baloxavir marboxil, Oseltamivir, the total percent recovery was
greater than 90%.
Conclusion: The method employed in this study is simple and quick to implement, as well as having appropriate
accuracy, precision, selectivity, and stability. The method's simplicity, as well as the fact that it uses quick protein
precipitation extraction with a shorter run time of 3.0 minutes per sample, make it appealing for high-throughput
bioanalysis of Baloxavir marboxil.