ABSTRACT
Objective: 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: 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: 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: 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.