Analysis of Sorbitol According to USP-NF Method (SP0810 8C)

According to the United States Pharmacopeia and the National Formulary (USP 41-NF 36*), analysis for the sorbitol should be carried out with a 10-cm length column filled with L34 packing material and meets following requirements. The SP0810 8C, a 10-cm column of SUGAR SP0810, confirmed the requirements were met.

System suitability requirements:
Resolution of mannitol and sorbitol: ≥ 2.0
Relative standard deviation (RSD) of sorbitol peak area: ≤ 2.0%

*The version at the time of the application acquisition.


Sample : 10 μL
(System suitabilitysolution)
Mannitol, Sorbitol 4.8 mg/g each
(Standard solution)
Sorbitol 4.8 mg/g

1. Mannitol
2. Sorbitol

Column       : Shodex SUGAR SP0810 8C (8.0 mm I.D. x 100 mm)
Eluent       : H2O 
Flow rate    : 0.7 mL/min
Detector     : RI (35 °C)
Column temp. : 50 °C