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KMID : 0370220070510030174
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Yakhak Hoeji
2007 Volume.51 No. 3 p.174 ~ p.178
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Quantitative Determination of Doxifluridine and 5-FU in Monkey Serum Using LC/MS/MS
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Woo Young-Ah
Kim Ghee-Hwan
Kim Won
Lee Jong-Hwa
Jeong Eun-Ju
Kim Jin-Ho
Park Kui-Lea
Kim Choong-Yong
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Abstract
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A reverse-phase high performance liquid chromatography method with electrospray ionization and detection by mass spectrometry is described for the simultaneous determination of doxifluridine and its active metabolite 5-flu-orouracil (5-FU) in monkey serum. The method has greater sensitivity and simpler process than previous published methods with good accuracy and precision. A proper liquid/liquid extraction was used to extract simultaneously doxifluridine and 5-FU which has considerable difference in the polarity. Extracts were analyzed using LC/MS/MS providing a short analysis time within 5 min. The lower limit of quantification was validated at 10.0 ng/ml of serum for both doxifluridine and 5-FU. Accuracy and precision of quality control (QC) samples for both analytes met FDA Guidance criteria of ±15% for average QC accuracy with coefficients of variation less than 15%. The method will be applicable for preclinical studies and bioequivalence studies.
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KEYWORD
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doxifluridine, 5-FU, LC/MS/MS, monkey, serum, simultaneous determination, validation
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