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*), analysis of zanamivir should be carried out with a column that meets following requir ments. The Asahipak NH2P-50 4E confirmed the requirements were met.

System suitability requirements:
   Resolution of zanamivir and talo-zanamivir (internal standard): ≥ 1.5
   Relative standard deviation (RSD): ≤ 1.5%

*The version at the time of the application acquisition.  


Sample : 20 μL
Zanamivir resolution solution
1. Zanamivir 0.05 mg/mL
2. talo-Zanamivir 2.5 μg/mL


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 °C

Sample Name Index

Operation Manual / Certificate of Analysis

Operation Manuals and Certificate of Analysis / Inspection Certificate for the following products can be downloaded here.

Product Name Index

Applications