学报Journal of China Pharmaceutical University 2019,50(6):694-698
收稿日期2019-
08-31通信作者*Tel :025-83271305E-mail :dongshenghe@cpu.edu **Tel :025-83271305E-mail :jiashengtu@cpu.edu 基金项目国家重大新药创制科技重大专项资助项目(No.2017ZX0910*******);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)气相谱法测定泊洛沙姆188中乙二醇、二甘醇和三甘醇含量
黄鸿升资料
雷雅娟,熊晔蓉,朱颜玥,段梦茹,孙春萌,何东升*,涂家生
**
(中国药科大学药学院,药用辅料及仿创药物研发评价中心,南京210009)
摘要采用气相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。选用谱柱VF-
17ms (30m ˑ0.53mm ,1.0μm ),程序升温,进样口温度270ħ,检测器温度290ħ,分流比10ʒ1。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%、张震岳再见歌词
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。
关键词泊洛沙姆188;气相谱法;乙二醇;二甘醇;三甘醇
中图分类号
R944;R917文献标志码A 文章编号1000-5048(2019)06-0694-05
doi :10.11665/j.issn.1000-5048.20190609
引用本文雷雅娟,熊晔蓉,朱颜玥,等.气相谱法测定泊洛沙姆188中乙二醇、二甘醇和三甘醇含量[J ].中国药科大学学报,2019,50(6):694-698.
Cite this article as :LEI Yajuan ,XIONG Yerong ,ZHU Yanyue ,et al .Determination of ethylene glycol ,diethylene glycol and triethylene glycol in
poloxamer 188by gas chromatography [J ].J China Pharm Univ ,2019,50(6):694-698.Determination of ethylene glycol ,diethylene glycol and triethylene glycol in poloxamer 188by gas chromatography
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 Pharma-
ceutical University ,
Nanjing 210009,China Abstract The gas chromatography method was developed for the determination of ethylene glycol ,diethylene glycol and triethylene glycol in poloxamer 188to provide scientific basis for the quality control.The samples was
separated on column VF-17ms (30m ˑ0.53mm ,
现在油价是多少>古天乐女友黄纪莹>亩和平方米1.0μm )with temperature programming ,inlet temperature was 270ʎC ,
detector temperature was 290ʎC and the split ratio was 10ʒ1.The method showed great linearity over the range of 6-15μg /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.Key words poloxamer 188;gas chromatography ;ethylene glycol ;diethylene glycol ;triethylene glycol
This work was supported by the National Science and Technology Major Project Significant New Drugs Creation (No.2017ZX0910*******)and the Project from Chinese Pharmacopeia Commission-Reform of the System of Evaluation ,Review
李耐阅王骁接吻照片
and Approval of Drugs and Medical Devices (No.ZG2017-
5-03)496