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Development of an Isotope-Dilution Liquid Chromatography/Mass Spectrometric Method for the Accurate Determination of Acetaminophen in Tablets

  • Shin, Hyun-Ju (Division of Metrology for Quality Life, Korea Research Institute of Standards and Science) ;
  • Kim, Byung-Joo (Division of Metrology for Quality Life, Korea Research Institute of Standards and Science) ;
  • Lee, Joon-Hee (Division of Metrology for Quality Life, Korea Research Institute of Standards and Science) ;
  • Hwang, Eui-Jin (Division of Metrology for Quality Life, Korea Research Institute of Standards and Science)
  • Received : 2010.06.19
  • Accepted : 2010.10.08
  • Published : 2010.12.20

Abstract

Acetaminophen (N-acetyl-p-aminophenol) is one of the most popular analgesic and antipyretic drugs. An isotope dilution mass spectrometric method based on LC/MS was developed as a candidate reference method for the accurate determination of acetaminophen in pharmaceutical product. After spiking an isotope labeled acetaminophen (acetyl-$^{13}C_2$, $^{15}N$-acetaminophen) as an internal standard, tablet extracts were analyzed by LC/MS in a selected reaction monitoring (SRM) mode to detect ions at m/z $152{\rightarrow}110$ and m/z $155{\rightarrow}111$ for acetaminophen and acetyl-$^{13}C_2$, $^{15}N$-acetaminophen, respectively. The repeatability and reproducibility of the developed ID/LC-MS method were tested for the validation and assessment of metrological quality of the method.

Keywords

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