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

LI Haoyu; TANG Baoqiang; HE Dongsheng; TU Jiasheng

doi:10.11665/j.issn.1000-5048.20220306

Journal of China Pharmaceutical University > 2022 > 53(3): 293-299. > DOI: 10.11665/j.issn.1000-5048.20220306

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

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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)

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Received Date: January 05, 2022
Revised Date: May 13, 2022

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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.
- cetomacrogol 1000,
- impurity,
- gas chromatography,
- ethylene oxide,
- 1,4-dioxane,
- ethylene glycol,
- diethylene glycol,
- triethylene glycol

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