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.
关键词
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
Keywords
HPGPC methodFerric carboxymaltoseWeight average molecular weightMolecular weight distribution