Sensitive Quantitation of Residual Phenylhydrazine in Antipyrine by LC-ICP-MS with Iodo Derivatization

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  • HARIGAYA Koki
    Analytical Research Laboratories, CMC Division, Mitsubishi Tanabe Pharma Corp.
  • YAMADA Hiroyuki
    Analytical Research Laboratories, CMC Division, Mitsubishi Tanabe Pharma Corp.
  • HORIMOTO Shingo
    Analytical Research Laboratories, CMC Division, Mitsubishi Tanabe Pharma Corp.
  • NISHI Hiroyuki
    Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Yasuda Women’s University
  • HAGINAKA Jun
    School of Pharmacy and Pharmaceutical Sciences, Mukogawa Women’s University

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抄録

Phenylhydrazine is a genotoxic impurity commonly used as a raw material in active pharmaceutical ingredients. In this study, a novel method, using inductively coupled plasma–mass spectrometry combined with two-dimensional liquid chromatography (LC-ICP-MS), was employed for the quantitation of residual phenylhydrazine in antipyrine. The compound 2,3,5-triiodobenzoyl chloride, which contains three iodine atoms, was investigated as a derivatization reagent. The DL 0.06 ppm was obtained, and the method was applied to the quantitation of residual phenylhydrazine in antipyrine. No residual phenylhydrazine was detected in five lots of antipyrine obtained from the commercial source.

収録刊行物

  • Analytical Sciences

    Analytical Sciences 30 (8), 845-850, 2014

    社団法人 日本分析化学会

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