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

Fosfomycin is one of the antibiotics having a relatively broad antibacterial spectrum. According to the United States Pharmacopeia and the National Formulary (USPNF 2021 Issue 1*), the ASSAY of “Fosfomycin Tromethamine” should be carried out with a column filled with L8 packing material (aminopropylsilane chemically bonded to totally porous silica gel). Meanwhile, this application shows that a polymer-based amino column, Asahipak NH2P-50 4E is also feasible analyzing fosfomycin following the similar conditions mentioned in the monogram.

(Note)
Asahipak NH2P-50 4E is a L82 column.

*The version at the time of the application acquisition.

Preparation method: Solution A

  1. (1)Mix 300 mg of fosfomycin tromethamine and 60 μL of water. Heat at 60 ℃ for 24 hr.
  2. (2)Add 20 mL of the eluent to (1).

Preparation method: System suitability solution

  1. (1)Dissolve 120 mg of fosfomycin tromethamine in 1 mL of Solution A.
  2.  

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

  1. 1.Fosfomycin
Column
Shodex Asahipak NH2P-50 4E (4.6 mm I.D. x 250 mm)
Eluent
10.89 g/L KH2PO4 aq.
Flow rate
1.0 mL/min
Detector
RI
Column temp.
40 ℃

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