Separation of Fosfomycin and its Thermal Decomposition Products (NH2P-50 4E)

Fosfomycin  is one of the antibiotics with a relatively broad antibacterial spectrum. According to the monograph of fosfomycin tromethamine in the United States Pharmacopeia and the National Formulary (USP-NF 2021 Issue 1*), the thermal decomposition products of fosfomycin tromethamine (Solution A) and the standard-added fosfomycin (System suitability solution) are separated by HPLC. In this application, the targets were separated by Asahipak NH2P-50 4E.

*The version at the time of the application acquisition.
(Preparation method: Solution A)
  (1) Mix 300 mg of fosfomycin tromethamine and 60 μL of water. Heat at 60 ° C for 24 hr.
  (2) Add 20 mL of the eluent to (1).

(Preparation method: System suitability solution)
  (1) Dissolve 120 mg of fosfomycin tromethamine in 1 mL of Solution A.

Sample: 5 μL
A: Solution A
B: System suitability solution

1. Fosfomycin

Column       : Shodex Asahipak NH2P-50 4E (4.6 mm I.D. x 250 mm)
Eluent       : 10.89 g/L K2HPO4 aq.
Flow rate    : 1.0 mL/min
Detector     : RI
Column temp. : 40 °C

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