ABSTRACT
OBJECTIVE:To establish a method for the determination of weight average molecular weight(Mw)and molecular weight distribution (D) of ferric carboxymaltose. METHODS:HPGPC method was adopted to detect the Mw and D of 3 batches of Ferric carboxymaltose injection (imported) and its raw material (self-made). The determination was performed on TSK G4000 PWXL column with 0.1% sodium azide solution with the flow rate of 0.5 ml/min. The detector was refractive index detector;the column temperature was set at 35 ℃,and sample size was 20 μl. The results were calculated with GPC software. RESULTS:RSDs of precision,stability and reproducibility tests were all lower than 3.0%(n=6);Mw and D of 3 imported samples were 157 667 and 1.30;those of self-made samples were 162 000 and 1.42. CONCLUSIONS:The method has high precision,good stability,repeat-ability and durability. It can be used for the determination of Mw and D of ferric carboxymaltose.
ABSTRACT
Objective To establish a method for determining the molecular weight (Mw) and molecular weight distribution of Iron Maltose Syrup. Methods HPGPC was used; PSS HEMA was used as column.Detector was differential refraction detector.Mobile phase was phosphate buffer solution (pH6.8) at 0.5 mL/min, column temperature was 45℃.Results The Mw of 3 batches of Iron Maltose Syrup were 45000-47000 Da with good linearity, precision and reproducibility.Conclusion The method is simple, reliable and accepted by the specification for controlling the molecular weight and weight distribution of Iron Maltose Syrup.
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Objective: To develop a high performance gel permeation chromatography (HPGPC) method for quality control of Tremella fuciformis polysaccharide. Methods: The separations were carried out with two series-wound columns including Shodex Sugar KS-804 (300 mm x 8 mm, 7 μm) and KS-805 (300 mm x 8 mm, 17 μm), water as mobile phase at flow rate 0.8 mL/min, column temperature at 40°C, injection volume 40 μL, and differential index detector. Results: T. fuciformis polysaccharide peak was located within 14.40-15.30 min and corresponding molecular weight was 1.26 × 106-1.39 × 106. The linearity was good during 0.01-2.0 mg/mL (r = 0.999). The polysaccharide concentration was 1.1-1.5 mg/mL and 0.8-1.1 mg/mL with precipitation of T. fuciformis polysaccharide and blue dextran as reference, respectively. LOD and LOQ were 0.8 and 2 μg, respectively. Conclusion: The method is simple, quick, and accurate, and has good repeatability and high sensitivity, which is fitful for quality control.
ABSTRACT
AIM:To study the isolation and composition of Cliffbean(Millettia pulchra kurz)polysaccharide.METHODS:Cliffbean was extracted by boiling water.The polysaccharide in the filtrate was precipitated fractionally by alcohol.The protein in the product was removed by Sevag method,and was further purified by DEAE ion-exchange cellulose(DEAE-52).The component of the saccharide was determined by GC and TLC.RESULTS:The polysaccharide obtained in this way didn't contain protein and nucleic acid.It showed a single polysaccharide when identified by means of Sephadex G-75 column or High Performance Gel Permeation Chromatography(HPGPC).It was composed of glucose and arabinose.CONCLUSION:Cliffbean polysaccharide was first isolated from its root and was one of the important components.