摘要
采用气相色谱法测定药用辅料泊洛沙姆188中3种残留杂质乙二醇、二甘醇和三甘醇的含量,为其质量控制提供科学依据。选用色谱柱VF-17ms(30 m×0.53 mm,1.0μm),程序升温,进样口温度270℃,检测器温度290℃,分流比10∶1。实验结果显示,乙二醇、二甘醇和三甘醇在6~15μg/mL范围内线性关系良好(r≥0.999);进样精密度RSD(n=8)分别为3.3%、3.0%和2.3%;平均回收率分别为99.05%(RSD=2.9%,n=9),102.20%(RSD=4.0%,n=9),101.91%(RSD=3.1%,n=9)。该方法系统适应性良好,准确度、精密度高,适用于泊洛沙姆188中乙二醇、二甘醇和三甘醇的测定,为泊洛沙姆188的生产及质量控制提供参考与指导。
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-17 ms(30 m×0.53 mm,1.0 μm) with temperature programming,inlet temperature was 270 ℃,detector temperature was 290 ℃ 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.
作者
雷雅娟
熊晔蓉
朱颜玥
段梦茹
孙春萌
何东升
涂家生
LEI Yajuan;XIONG Yerong;ZHU Yanyue;DUAN Mengru;SUN Chunmeng;HE Dongsheng;TU Jiasheng(Center for Research Development and Evaluation of Pharmaceutical Excipients and Generic Drugs,School of Pharmacy,China Pharmaceutical University,Nanjing 210009,China)
出处
《中国药科大学学报》
CAS
CSCD
北大核心
2019年第6期694-698,共5页
Journal of China Pharmaceutical University
基金
国家重大新药创制科技重大专项资助项目(No.2017ZX09101001006)
国家药典委员会-药品医疗器械审评审批制度改革专项课题资助(No.ZG2017-5-03).
关键词
泊洛沙姆188
气相色谱法
乙二醇
二甘醇
三甘醇
poloxamer 188
gas chromatography
ethylene glycol
diethylene glycol
triethylene glycol
