Determination of Raw Materials and Preparations of Baloxavir Marboxil

OBJECTIVE To establish a method for the determination of baloxavir marboxil raw materials and tablets.

METHODS The contents of baloxavir marboxil was determined by HPLC. The column was YMC-Triart ExRS C₁₈(250 mm×4.6 mm, 5 μm); the mobile phase was 0.1% phosphoric acid-acetonitrile-methyl(30∶35∶35); the column temperature was 30 ℃; the flow rate was 1.0 mL·min⁻¹; the detection wavelength was 259 nm.

RESULTS The main peak was well separated from the excipients and various impurity peaks, indicating good specificity of the method. In the concentration range of 198.49–595.498 μg·mL⁻¹, the linear relationship between the peak area and the concentration was good, with r of 0.9997. The recovery rates ranged from 99.80% to 101.39%, with average recovery rates of 100.83% for the raw materials and 100.29% for the tablets.

CONCLUSION The method is reasonable, accurate and specific, which can be used for the determination of baloxavir marboxil and its tablets.