Safety Monitoring

Application of partition coefficient and phase ratio selection in determining genotoxic impurity benzene by HS-GC

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  • 1. Linyi People’s Hospital,Linyi 276003,China;
    2. Linyi Vocational College of Science and Technology,Linyi 276017,China

Revised date: 2021-03-03

  Online published: 2024-07-15

Abstract

Objective: To established a method for the determination of genotoxic impurity benzene residues in drug, to provide a basis for the determination of benzene in drug analysis. Methods: A ZB-50 capillary column(30 m×0.53 mm×1.0 μm)was used,the temperature program for the column was as follows:initially heated at 40 ℃ for 1 min, increased to 180 ℃ at a speed of 25 ℃·min-1 and lasted for 3 min. The inlet temperature was 220 ℃ and FID detector -1 temperature was set at 250 ℃ . The split ratio was 10∶1 and the flow rate of the carrier gas(N2)was 2.0 mL·min . Headspace conditions were as follows:the temperature and the time of shaking for the sample were 90 ℃ and 20 min. Results: Benzene had a good linear relationship within the concentration range of 0.034-0.407 µg·mL-1r=0.999 5). The average recoveries(n=9)were 92.3%(RSD=2.4%). The limit of detection was 11.0 ng·mL-1 and the limit of quantification was 34.0 ng·mL-1. Benzene was not detected in the 5 batches of samples. Conclusion: The established method greatly improved the detection efficiency of benzene residues in pharmaceuticals.

Cite this article

PENG Ji-ming, CHEN Na-na, FUYao, LI Ze, LIU Wen-qi . Application of partition coefficient and phase ratio selection in determining genotoxic impurity benzene by HS-GC[J]. Chinese Journal of Pharmaceutical Analysis, 2021 , 41(6) : 1029 -1035 . DOI: 10.16155/j.0254-1793.2021.06.13

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