Analysis of Lactulose According to JP Method (SP0810)

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

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