Analysis of Zanamivir According to USP-NF Method (NH2P-50 4E)

Zanamivir is a neuraminidase inhibitor, and it is effective in the treatment of influenza caused by influenza A and B viruses. According to the United States Pharmacopeia and the National Formulary (USP 37-NF 32*), "ASSAY" for "Zanamivir" should be carried out with a column filled with L82 packing material. The Asahipak NH2P-50 4E, a column filled with L82 packing material, confirmed the requirements were met.

System suitability requirementsResolution between zanamivir and talo-zanamivir (Resolution solution): ≥ 1.5
Relative standard deviation (RSD) (Standard solution): ≤ 1.5%

*The version at the time of the application acquisition.

Sample: 20 µL
(Resolution solution) 2.5 µg/mL of talo-zanamivir and 0.05 mg/mL of zanamivir in eluent

  1. 1.Zanamivir
  2. 2.talo-Zanamivir
Column
Shodex Asahipak NH2P-50 4E (4.6 mm I.D. x 250 mm)
Eluent
Acetonitrile and 7.5 mM sulfuric acid (60:40) Adjust with ammonia TS to a pH of 6.2
Flow rate
1.5 mL/min
Detector
UV (234 nm)
Column temp.
30 ℃

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