Determination of Weight Average Molecular Weight and Molecular Weight Distribution of Ferric Carboxy-maltose by HPGPC
10.6039/j.issn.1001-0408.2016.22.13
- VernacularTitle:HPGPC法测定羧基麦芽糖铁重均分子质量和分子质量分布
- Author:
Qiangwei LI
;
Qiang LI
;
Yun ZHENG
;
Liang ZHOU
- Publication Type:Journal Article
- Keywords:
HPGPC method;
Ferric carboxymaltose;
Weight average molecular weight;
Molecular weight distribution
- From:
China Pharmacy
2016;27(22):3066-3068
- CountryChina
- Language:Chinese
-
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.
