• 中国中文核心期刊
  • 中国科学引文数据库核心期刊
  • 中国科技核心期刊
  • 中国高校百佳科技期刊
高级检索

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

雷雅娟, 熊晔蓉, 朱颜玥, 段梦茹, 孙春萌, 何东升, 涂家生

雷雅娟, 熊晔蓉, 朱颜玥, 段梦茹, 孙春萌, 何东升, 涂家生. 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[J]. 中国药科大学学报, 2019, 50(6): 694-698. DOI: 10.11665/j.issn.1000-5048.20190609
引用本文: 雷雅娟, 熊晔蓉, 朱颜玥, 段梦茹, 孙春萌, 何东升, 涂家生. 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[J]. 中国药科大学学报, 2019, 50(6): 694-698. DOI: 10.11665/j.issn.1000-5048.20190609
shu
LEI Yajuan, XIONG Yerong, ZHU Yanyue, DUAN Mengru, SUN Chunmeng, HE Dongsheng, TU Jiasheng. Determination of ethylene glycol, diethylene glycol and triethylene glycol in poloxamer 188 by gas chromatography[J]. Journal of China Pharmaceutical University, 2019, 50(6): 694-698. DOI: 10.11665/j.issn.1000-5048.20190609
Citation: LEI Yajuan, XIONG Yerong, ZHU Yanyue, DUAN Mengru, SUN Chunmeng, HE Dongsheng, TU Jiasheng. Determination of ethylene glycol, diethylene glycol and triethylene glycol in poloxamer 188 by gas chromatography[J]. Journal of China Pharmaceutical University, 2019, 50(6): 694-698. DOI: 10.11665/j.issn.1000-5048.20190609
shu

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

  • 中国药科大学药学院，药用辅料及仿创药物研发评价中心

基金项目: 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)

Determination of ethylene glycol, diethylene glycol and triethylene glycol in poloxamer 188 by gas chromatography

    摘要
  • 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，1.0 μm)，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6~15 μg/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。
    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.
    • HTML全文
    • 参考文献(15)
  • [1] Paavola A,Bernards CM,Rosenberg PH.Controlled release ibuprofen-poloxamer gel for epidural use:a pharmacokinetic study using microdialysis in pigs[J].Eur J Pharm Biopharm,2016,108:180-186.
    [2] Bujňáková Z,BalហM,Zdurieníková M,et al.Preparation,properties and anticancer effects of mixed As4S4/ZnS nanoparticles capped by Poloxamer 407[J].Mater Sci Eng C Mater Biol Appl,2017,71:541-551.
    [3] Liu DF,Jiang T,Cai WH,et al.An in situ gelling drug delivery system for improved recovery after spinal cord injury[J].Adv Healthc Mater,2016,5(12):1513-1521.
    [4] Mao J,Liu SJ,Ai M,et al.A novel melittin nano-liposome exerted excellent anti-hepatocellular carcinoma efficacy with better biological safety[J].J Hematol Oncol,2017,10(1):71.
    [5] Yu SH,Zhang XY,Tan GX,et al.A novel pH-induced thermosensitive hydrogel composed of carboxymethyl chitosan and poloxamer cross-linked by glutaraldehyde for ophthalmic drug delivery[J].Carbohydr Polym,2017,155:208-217.
    [6] Nagesh IV,Koley KC,Sen S,et al.Ethylene glycol poisoning[J].Med J Armed Forces India,2015,71(Suppl 1):S36-S38.
    [7] Fowles J,Banton M,Klapacz J,et al.A toxicological review of the ethylene glycol series:commonalities and differences in toxicity and modes of action[J].Toxicol Lett,2017,278:66-83.
    [8] Schep LJ,Slaughter RJ,Temple WA,et al.Diethylene glycol poisoning[J].Clin Toxicol,2009,47(6):525-535.
    [9] Devoti E,Marta E,Belotti E,et al.Diethylene glycol poisoning from transcutaneous absorption[J].Am J Kidney Dis,2015,65(4):603-606.
    [10] Chinese Pharmacopoeia Commission.Chinese Pharmacopoeia:part 4(中华人民共和国药典:四部)[S].Beijing:China Medical Science Press,2015:530-531.
    [11] Li LL,Wang HP,Tian HW,et al.Determination of 6 residual solvents in selexipag by headspace gas chromatography[J].J China Pharm Univ(中国药科大学学报),2018,49(1):93-96.
    [12] Imbert L, Saussereau E, Lacroix C. Analysis of eight glycols in serum using LC-ESI-MS-MS[J].J Anal Toxicol,2014,38(9):676-680.
    [13] Teglia CM,Montemurro M,De Zan MM,et al.Multiple responses optimization in the development of a headspace gas chromatography method for the determination of residual solvents in pharmaceuticals[J].J Pharm Anal,2015,5(5):296-306.
    [14] Fan CL,Zhang YH,Wang C,et al.Determination of purity and impurities of ethylene glycol for industrial use by gas chromatography[J].Chin J Chromatogr(色谱),2019,37(1):116-120.
    [15] Qin XY,Wu RR,Shen Y,et al.Effects of polysorbate 80 of different sources on the quality of docetaxel injection[J].J China Pharm Univ(中国药科大学学报),2012,43(4):312-317.
    • 相关文章
    • 施引文献
  • 资源附件(0)
计量
  • 文章访问数: 
  • HTML全文浏览量:  0
  • PDF下载量: 
  • 被引次数: 0
出版历程
  • 刊出日期:  2019-12-24

目录

    /

    返回文章
    返回

    版权所有：《中国药科大学学报》编辑部苏ICP备05007142号

    地址：江苏省南京市鼓楼区童家巷24号（210009）电话: 025-83271566E-mail: xuebao@cpu.edu.cn

    本系统由 北京仁和汇智信息技术有限公司 开发  百度统计

    访问量：323932

    x 关闭 永久关闭