According to USP (United States Pharmacopeia), for the assay of maltitol, a column packed with L34 packing with a length of 10 cm is recommended for the analysis.
The system suitability requirements in the monograph for maltitol are as follows:
1) For standard solution: The relative standard deviation should be not more than 2.0 %
2) For system suitability solution: The resolution between maltitol and sorbitol is not less than 2.0
In addition, in the monograph for maltitol solution, the requirements are:
3) For standard solution: The tailing factor of maltitol and sorbitol should be less than 1.2, and the relative standard deviation should be not more than 2.0 %
As the results below show, SUGAR SP0810 8C, a 10 cm version of the SUGAR SP0810 designed for this analysis, meets all the system suitability requirements.
Sample: 10 μL
(Standard solution)
Maltitol 10 mg/g, Sorbitol 1.6 mg/g
(System suitability solution)
Maltitol, Sorbitol 4.8 mg/g each
1. Maltitol
2. Sorbitol
Column : Shodex SUGAR SP0810 8C (8.0 mm I.D. x 100 mm) Eluent : H2O Flow rate : 0.5 mL/min Detector : Shodex RI (35 ℃) Column temp. : 60 ℃
