Objective:

2

To establish a method for determining arabinose

mannose

fructopyranose and amylaceum in Shenxiong glucose injection by UPLC-MS/MS

so as to provide the basis for the scientific evaluation of the quality of Shenxiong glucose injection

and lay a foundation for the safe use of drugs in clinic.

Method:

2

Domestic GDX-403 solid-phase extraction column was used to purify Waters ACQUITY UPLC BEH Xbridge Amide column (2.1 mm×100 mm

1.7 μm)at the column temperature of 35 ℃

and the mobile phase was 0.1%ammonia

0.1%acetonitrile-0.1%ammonia water and water 85∶15. The contents of arabinose

mannose

fructose and glucose in Shenxiong glucose injection were determined by UPLC-MS/MS with a flow rate of 0.3 mL·min

-1

.

Result:

2

A method was established to determine arabinose

mannose

fructopyranose and amylaceum in Shenxiong glucose injection. The concentration range of arabinose

mannose

fructopyranose and amylaceum showed a good linear relationship with the peak area

with a good repeatability and precision. Recoveries were 98.43%

102.13%

100.72%

101.75%

and RSD were 2.4%

1.3%

3.1%

2.7%. Arabinose and mannose content were stable in five batches of Shenxiong glucose injection.

Conclusion:

2

The method is simple and specific. Compared with the determination of total sugar

the method is more scientific and stable

and can be used for the quality control of Shenxiong glucose injection.