• 中国精品科技期刊
  • 中国高校百佳科技期刊
  • 中国中文核心期刊
  • 中国科学引文数据库核心期刊
Advanced Search
LI Haoyu, TANG Baoqiang, HE Dongsheng, TU Jiasheng. Determination of residual impurities in pharmaceutical excipient cetomacrogol 1000 by gas chromatography[J]. Journal of China Pharmaceutical University, 2022, 53(3): 293-299. DOI: 10.11665/j.issn.1000-5048.20220306
Citation: LI Haoyu, TANG Baoqiang, HE Dongsheng, TU Jiasheng. Determination of residual impurities in pharmaceutical excipient cetomacrogol 1000 by gas chromatography[J]. Journal of China Pharmaceutical University, 2022, 53(3): 293-299. DOI: 10.11665/j.issn.1000-5048.20220306
shu

Determination of residual impurities in pharmaceutical excipient cetomacrogol 1000 by gas chromatography

  • 1.

    Center for Research Development and Evaluation of Pharmaceutical Excipients and Generic Drugs, School of Pharmacy, China Pharmaceutical University, Nanjing 210009

  • 2.

    National Medical Products Administration (NMPA) Key Laboratory for Research and Evaluation of Pharmaceutical Preparations and Excipients, Nanjing 210009, China

Funds: This study was supported by China National Key Hi-Tech Innovation Project for the R&D of Novel Drugs (No.2017ZX09101001-006-002) and the Drug Standard Establishment and Revision Project of Chinese Pharmacopoeia Commission (No.2020Y047)
More Information
  • Received Date: January 05, 2022
  • Revised Date: May 13, 2022
    Graphical Abstract
    • Abstract
  • For the quality control of cetomacrogol 1000, a gas chromatographic method for the determination of residual impurities in cetomacrogol 1000, such as ethylene oxide, 1, 4-dioxane, ethylene glycol, diethylene glycol and triethylene glycol, was established and validated.The DB-1 column with headspace injection was used to detect ethylene oxide and 1, 4-dioxane with the inlet temperature of 150 °C, the FID temperature of 250 °C, the headspace equilibration temperature of 70 °C and the equilibration time of 45 min.The VF-17MS column with liquid injection was used to detect ethylene glycol, diethylene glycol and triethylene glycol with the inlet temperature of 270 °C, and the FID temperature of 290 °C.The results showed that ethylene oxide and 1,4-dioxane have a good linearity within their specified addition amount ranges (r > 0.999), with the RSD of precision of below 8.0% and the average recovery rates of 90.6% and 101.2%; and that ethylene glycol, diethylene glycol and triethylene glycol also have a good linearity between 3 ? 60 μg/mL (r > 0.999), with the RSD of precision of below 3.0%, and the recovery rates of 96% ~ 103%.The method established in this study has good specificity, linearity, precision and recovery rate, which can effectively detect the multi-component and trace impurities.
    • FullText(HTML)
    • References (13)
  • [1]
    . ACS Omega，2021，6（32）：20975-20983.
    [2]
    Eccleston GM. Structure and rheology of cetomacrogol creams：the influence of alcohol chain length and homologue composition［J］. J Pharm Pharmacol，1977，29（3）：157-162.
    [3]
    Secretin L，Anyakudo F，Gilissen L，et al. Qualitative analysis of cetomacrogol creams by thin-layer chromatography-flame ionization detection （TLC-FID）［J］. SN Appl Sci，2020，2（9）.doi：https：//doi.org/10.1007/s42452-020-03389-4.
    [4]
    Chen L，Zhang Y，Zheng A，et al. Thoughts on the high quality development of pharmaceutical excipients industry in China［J］. Chin Pharm Aff （中国药事），2021，35（9）：972-977.
    [5]
    Liu J，Wu Y，Li HL. Determination of ethylene oxide and dioxane in PEG 10000 by headspace gas chromatography［J］. Drug Stand China（中国药品标准），2017，18（2）：117-119.
    [6]
    Yi CC，Sha RL，Chen QY，et al. Quality study of pharmaceutical excipient polysorbate 80［J］. J China Pharm Univ（中国药科大学学报），2020，51（2）：168-174.
    [7]
    Lei YJ，Xiong YR，Zhu YY，et al. Determination of ethylene glycol，diethylene glycol and triethylene glycol in poloxamer 188 by gas chromatography［J］. J China Pharm Univ（中国药科大学学报），2019，50（6）：694-698.
    [8]
    Gao S，Zhu S，Zhao X，et al. Comparative study on HPLC and GC methods for determination of ethylene glycol and diethylene glycol residues in polyethylene oxide［J］. Chin J Pharm Anal （药物分析杂志），2020，40（10）：1820-1827.
    [9]
    Duan MR，He DS，Sun HM，et al. Determination of epoxide impurity in Poloxamer188 by gas chromatography［J］. J Pharm Res（药学研究），2020，39（6）：331-335，340.
    [10]
    The British Pharmacopoeia Commission. British Pharmacopoeia：Monograph 1123［S］. London：The Stationery Office，2020：1123-1125.
    [11]
    The United States Pharmacopeial Convention. United States Pharmacopoeia：Vol 31（3）［S］. 43th ed. Rockville：The United States Pharmacopeial Convention，2020：5955-5957.
    [12]
    World Health Organization. The International Pharmacopoeia［EB/OL］. 10th ed. https：//digicollections.net/phint/2020/index.htmL#p/home.
    [13]
    Chinese Pharmacopoeia Commission. Chinese Pharmacopoeia：part 4（中华人民共和国药典：四部）［S］. Beijing：China Medical Science Press，2020：819-820.
    • Related Articles

  • Related Articles

    [1]PAN Kemeng, CHEN Song, GAO Xiangdong, YAO Wenbing. Effects and mechanisms of microRNA-23b on neuronal apoptosis induced by Aβ25-35[J]. Journal of China Pharmaceutical University, 2021, 52(4): 480-486. DOI: 10.11665/j.issn.1000-5048.20210411
    [2]SUN Yan, GAO Xiangdong, CHEN Song. Effect and mechanism of FGF21 on astrocyte damage induced by Aβ25-35[J]. Journal of China Pharmaceutical University, 2019, 50(4): 490-496. DOI: 10.11665/j.issn.1000-5048.20190415
    [3]PENG Xuehan, XIE Wenmin, LI Ji, YU Feng. Comparative investigation of in vitro antitumor activity of Ganoderma lucidum spore oil[J]. Journal of China Pharmaceutical University, 2019, 50(1): 81-86. DOI: 10.11665/j.issn.1000-5048.20190111
    [4]YU Haiyang, CHEN Song, XU Zheng, GAO Xiangdong, YAO Wenbing. Protective effect of fibroin peptides on Aβ25-35-induced injury in SH-SY5Y cells and its mechanism[J]. Journal of China Pharmaceutical University, 2017, 48(5): 609-613. DOI: 10.11665/j.issn.1000-5048.20170517
    [5]WANG Xiao-jie, XINHUA Nabi, SUN Yu. Effects of active peptide extracted from cheese whey on the expression of PPARγ mRNA and NF-κB activity in 3T3-L1 adipocytes[J]. Journal of China Pharmaceutical University, 2012, 43(5): 449-452.
    [6]CHEN Hong, YANG Jie, CUI Wei-xi, WANG Qiang. Effects and mechanism of ursolic acid on lipopolysaccharide-induced THP-1 cells[J]. Journal of China Pharmaceutical University, 2011, 42(5): 447-451.
    [7]XU Ling-jie, LI Cong, ZHANG Mian, DAI Yue, HUANG Fang. Effect of the ethyl acetate extract of Farfarae Flos on inflammatory factors[J]. Journal of China Pharmaceutical University, 2011, 42(1): 64-67.
    [8]Transcription factors as new targets for cancer therapy[J]. Journal of China Pharmaceutical University, 2010, 41(2): 97-103.
    [10]Effect of Nerve Regeneration Factor on GAP-43 and NF-L Gene Expression in Dorsal Roots Ganglia Cell[J]. Journal of China Pharmaceutical University, 2001, (3): 73-76.

Catalog

    Get Citation
    PDF
    XML
    Article views (277) PDF downloads (363) Cited by()
    Turn off MathJax
    Article Contents
    Abstract
    References
    Related Articles

    Copyright © Journal of China Pharmaceutical University苏ICP备12050101号-2

    Address：24 Tongjia Lane, Nanjing City, Jiangsu Province （210009）Tel: 025-83271566E-mail: xuebao@cpu.edu.cn

    Supported by: Beijing Renhe Information Technology Co., Ltd.  Baidu Analytics

    Total visits：365451

    /

    DownLoad:  Full-Size Img  PowerPoint
    Return
    Return