According to the fourth part of the 2025 edition of the Chinese Pharmacopoeia, regarding the determination of related substances and content of mannitol, the separation degree between the mannitol peak and the sorbitol peak in the system suitability solution (1) chromatogram should be greater than 2.0; The separation degree of the first chromatographic peak of maltitol and isomaltulose in the system suitability solution (2) chromatogram should meet the requirements; The peak area of other individual unknown impurities shall not exceed twice the main peak area (0.10%) of the system suitability solution (3); The sum of the peak areas of each impurity shall not exceed the main peak area of the control solution (2.0%).

Chromatographic conditions——

Chromatographic column: Ecosil Sugar Ca, 7.8X 300mm, 8 μ um

Mobile phase: water

Detector: Differential Refraction Detector 50 ° C

Column temperature: 80 ° C

Flow rate: 0.5mL/min

The Ecosil Sugar Ca liquid chromatography column was tested under the chromatographic conditions required by the pharmacopoeia. In the chromatogram of the system suitability solution (1), the separation degree between the mannitol peak and the sorbitol peak was 5.9, which is higher than the standard requirement of 2:0; In the chromatogram of system suitability solution (2), the separation degree of the first chromatographic peak of maltitol and isomaltulose is 2.3, which is higher than the standard requirement of 1.5. The signal-to-noise ratio in system solution (3) is 30, which meets the quantitative limit requirement and can be used for the determination of this project.