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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-<TEX>$^{13}C_2$</TEX>, <TEX>$^{15}N$</TEX>-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 <TEX>$152{\rightarrow}110$</TEX> and m/z <TEX>$155{\rightarrow}111$</TEX> for acetaminophen and acetyl-<TEX>$^{13}C_2$</TEX>, <TEX>$^{15}N$</TEX>-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.
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