According to the Japanese Pharmacopeia (JP; 17th edition*), analysis of lactulose should be carried out with a column filled with strong acid cation exchange gel and meets following requirements. The SUGAR SP0810 confirmed the requirements were met.
System suitability requirements:
Elution order: lactulose, internal standard (mannitol)
Resolution (lactulose, mannitol): ≥ 8 (injection volume 10 μL)
Relative standard deviation (RSD) of lactose, lactulose, and galactose peak height ratios
against the internal standard: ≤ 2.0 % (injection volume 20 μL)
*The version at the time of the application acquisition.
Sample : 10 µL
1. Lactose 0.8 mg/mL
2. Lactulose 10 mg/mL
3. Galactose 1.6 mg/mL
4. Mannitol 10 mg/mL
*dissolved in H2O
Column : Shodex SUGAR SP0810 (8.0 mm I.D. x 300 mm) Eluent : H2O Flow rate : 0.5 mL/min Detector : RI Column temp. : 75 °C
Sample Name Index
Operation Manual / Certificate of Analysis
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