고성능 박층 크로마토그래프를 이용한 실데나필과 그 유사 물질의 정량에 관한 연구

Determination of Sildenafil and Its Related Substances Using High Performance Thin Layer Chromatography

  • 최현철 (식품의약품안전청 의약품평가부) ;
  • 강신정 (식품의약품안전청 의약품평가부) ;
  • 윤미옥 (식품의약품안전청 의약품평가부) ;
  • 박상애 (식품의약품안전청 의약품평가부) ;
  • 김호정 (식품의약품안전청 의약품평가부) ;
  • 위세승 (식품의약품안전청 의약품평가부) ;
  • 김자연 (식품의약품안전청 의약품평가부) ;
  • 차기원 (인하대학교 화학과)
  • Choi, Hyun-Cheol (Drug Evaluation in Korea Food & Drug Administration) ;
  • Kang, Sin-Jung (Drug Evaluation in Korea Food & Drug Administration) ;
  • Yun, Mi-Ok (Drug Evaluation in Korea Food & Drug Administration) ;
  • Park, Sang-Aeh (Drug Evaluation in Korea Food & Drug Administration) ;
  • Kim, Ho-Jeong (Drug Evaluation in Korea Food & Drug Administration) ;
  • We, Sae-Seung (Drug Evaluation in Korea Food & Drug Administration) ;
  • Kim, Ja-Yeon (Drug Evaluation in Korea Food & Drug Administration) ;
  • Cha, Ki-Won (Department of chemistry, Inha university)
  • 투고 : 2002.11.11
  • 심사 : 2003.01.17
  • 발행 : 2003.02.25

초록

고성능박층크로마토그래프 (HPTLC : high performance thin layer chromatography)를 이용하여 실데나필과 그 유사체인 바데나필, 호모실데나필, 타다나필등을 신속하고 정확하게 분리정량하는 방법을 연구하였다. 실데나필 및 유사실데나필에 대한 최적의 분리조건과 각 성분의 고유한 UV스펙트럼을 얻었다. 각 성분의 검정선의 직선범위는 4성분에 대하여 약 $1.0{\sim}56.5{\mu}g/mL$이며, 상관계수($r^2$)은 모두 0.999이상 이었다. 정량한계는 약 $1.0{\sim}2.3{\mu}g/mL$, 검출한계는 약 $0.8{\sim}1.8{\mu}g/mL$이었으며, 정밀성을 시험한 결과 분산계수 (C.V.)가 2.5% 이하였다. 동 시험법으로 건강보조식품중 함유되어 있는 실데나필 및 그 유사체의 확인 및 함유량을 매우 신속하게 측정할 수 있었다.

The rapid and sensitive determination method of sildenafil and its related compounds (Vardenafil, Homosildenafil, Tadanafil.) has been investigated using high performance thin layer choromatography (HPTLC). Optimizing separation conditions and simultaneous determination method of these compounds were studied. The calibration curves of those compounds at 254 nm was found to be linear in the range of $1.0{\sim}56.5{\mu}g/mL$, respectively. The detection limts (LOD) and quantification limits (LOQ) of these were found to be $0.8{\sim}1.8{\mu}g/mL$ and $1.0{\sim}2.3{\mu}g/mL$. The coefficient of variation (C.V.) were less than 2.5%. Finally, the present method was applied to determine sildenafil and its related substances in dietary supplement.

키워드

참고문헌

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