Quantitative Analysis of Sucrose in Saccharated Iron Oxide Injection (VG-50 4E)

The United States Pharmacopeia and the National Formulary (USPNF 2022 Issue 2*) uses a silica base amino column to analyze sucrose in iron sucrose injection.
In this application, HILICpak VG-50 4E, a polymer-based amino column, was used to analyze sucrose in saccharated iron oxide injection, using the USP monograph as a reference. With the given conditions, the calibration curve for sucrose obtained showed a high linearity with a coefficient of determination R² = 0.999 in the range of 13 – 23 mg/mL.
This shows the method’s feasibility for the quantitative analysis of sucrose in pretreated saccharated iron oxide injections.

*The version at the time of the application acquisition.

Sample pretreatment

1. (1)Put a 1.875 g saccharated iron oxide sample and 1.25 mL pure water in a 25 mL beaker to mix. Add 1.25 mL of sodium dihydrogen phosphate aqueous solution (30 g/ 50 mL) and mix again.
2. (2)Leave it for 10 minutes. Add water to make up to 25 mL.
3. (3)Perform ultrafiltration for 15 minutes at 3000 rpm.
4. (4)Pass through a 0.45 μm membrane filter. Discard the first 2 mL of the filtrate. Use the rest for the HPLC analysis.

Sample: 20 µL
Pretreated saccharated ferric oxide solution

1. Sucrose

 Columns : Shodex HILICpak VG-50 4E (4.6 mm I.D. x 250 mm)
 Eluent : CH3CN/H2O=79/21 
 Flow rate : 1.5 mL/min
 Detector : RI (25 ℃)
 Column temp. : 25 ℃