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目的:建立测定羧基麦芽糖铁重均分子质量(Mw)和分子质量分布(D)的方法。方法:采用高效凝胶渗透色谱法(HPGPC) 检测3批羧基麦芽糖铁注射液(进口)和羧基麦芽糖铁原料(自制)的Mw和D。色谱柱为TSK G4000 PWXL,流动相为0.1%叠氮化钠溶液,流速为0.5 ml/min,检测器为示差折光检测器,柱温为35 ℃,进样量为20 μl。采用GPC软件计算结果。结果:精密度、稳定性、重复性试验的RSD均小于3.0%(n=6);进口样品中Mw为157 667,D为1.30;自制品的Mw为162 000,D为1.42。结论:该方法精密度、稳定性、重复性、耐用性均较好,且操作简便,可用于羧基麦芽糖铁Mw和D的检测。
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, repeatability and durability. It can be used for the determination of Mw and D of ferric carboxymaltose.
高效凝胶渗透色谱法羧基麦芽糖铁重均分子质量分子质量分布
HPGPC methodFerric carboxymaltoseWeight average molecular weightMolecular weight distribution
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