Determination of ethylene glycol, diethylene glycol and triethylene glycol in poloxamer 188 by gas chromatography
10.11665/j.issn.1000-5048.20190609
- VernacularTitle:气相色谱法测定泊洛沙姆188中乙二醇、二甘醇和三甘醇含量
- Author:
Yajuan LEI
1
;
Yerong XIONG
;
Yanyue ZHU
;
Mengru DUAN
;
Chunmeng SUN
;
Dongsheng HE
;
Jiasheng TU
Author Information
1. 中国药科大学药学院,药用辅料及仿创药物研发评价中心
- Publication Type:Journal Article
- Keywords:
poloxamer 188;
gas chromatography;
ethylene glycol;
diethylene glycol;
triethylene glycol
- From:
Journal of China Pharmaceutical University
2019;50(6):694-698
- CountryChina
- Language:Chinese
-
Abstract:
The gas chromatography method was developed for the determination of ethylene glycol, diethylene glycol and triethylene glycol in poloxamer 188 to provide scientific basis for the quality control. The samples was separated on column VF-17ms(30 m×0. 53 mm, 1. 0 μm)with temperature programming, inlet temperature was 270 °C, detector temperature was 290 °C and the split ratio was 10 ∶1. The method showed great linearity over the range of 6-15 μg/mL(r≥0. 999). The injection precision(n=8)of the three residual impurities were 3. 3%, 3. 0%, 2. 3% and the average recoveries were 99. 05%(RSD=2. 9%, n=9), 102. 20%(RSD=4. 0%, n=9), 101. 91%(RSD=3. 1%, n=9), respectively. The analytical method is specific, accurate and sensitive, which is suitable for the determination of ethylene glycol, diethylene glycol and triethylene glycol in poloxamer 188, providing reference and guidance for the production and quality control of poloxamer 188.