LC/MS/MS를 이용한 원숭이 혈액에서의 Doxifluridine과 대사체 5-FU 동시분석법 개발 및 Validation

• 영문명: Quantitative Determination of Doxifluridine and 5-FU in Monkey Serum Using LC/MS/MS
• 발행기관: 대한약학회
• 저자명: 우영아(Young Ah Woo) 김기환(Ghee Hwan Kim) 김원(Won Kim) 이종화(Jong Hwa Lee) 정은주(Eun Ju Jeong) 김진호(Jin Ho Kim) 박귀례(Kui Lea Park) 김충용(Choong Yong Kim)
• 간행물 정보: 『약학회지』제51권 제3호 (2007년), 174~178쪽, 전체 5쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2007.06.30

영문 초록

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-fluorouracil(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 10.0ng/㎖ 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.

키워드

doxifluridine 5-FU LC/MS/MS monkey serum simultaneous determination validation