근적외선 분광법을 이용한 디아제팜정에서 디아제팜의 정량

Determination of Diazepam in Intact Diazepam Tablets Using Near Infrared Spectroscopy

  • 최현철 (식품의약품안전청 의약품평가부) ;
  • 강신정 (식품의약품안전청 의약품평가부) ;
  • 윤미옥 (식품의약품안전청 의약품평가부) ;
  • 이수정 (식품의약품안전청 의약품평가부) ;
  • 김호정 (식품의약품안전청 의약품평가부) ;
  • 김지연 (식품의약품안전청 의약품평가부) ;
  • 차기원 (인하대학교 화학과)
  • Choi, Hyun Cheol (Drug Evaluation in Korea Food & Drug Administration) ;
  • Kang, Shin Jung (Drug Evaluation in Korea Food & Drug Administration) ;
  • Youn, Mi Ok (Drug Evaluation in Korea Food & Drug Administration) ;
  • Lee, Su Jung (Drug Evaluation in Korea Food & Drug Administration) ;
  • Kim, Ho Jung (Drug Evaluation in Korea Food & Drug Administration) ;
  • Kim, Ji Yeon (Drug Evaluation in Korea Food & Drug Administration) ;
  • Cha, Ki Won (Department of Chemistry, Inha University)
  • 투고 : 2002.04.16
  • 발행 : 2002.06.25

초록

인근적외선 분광법(Near infrared spectroscopy, NIRS)으로 얻은 디아제팜정의 스펙트럼을 부분최소자승법(Partial least squares regression, PLSR)으로 처리하여 디아제팜정에서 디아제팜을 신속하고 간단하게 분석하는 방법을 연구하였다. 2 mg 및 5 mg 의 디아제팜정을 이용하여 검정선을 작성하고, 이 검정선의 직선성, 정량범위, 재현성 등을 검토하여 본 분석법의 정확성을 검증하였다. 2 mg의 디아제팜의 검정선의 상관계수는 0.9416이고, 검정선 표준오차(SEC)는 0.018%이였다. 5 mg의 디아제팜의 검정선의 상관계수는 0.9157이고, 검정선오차는 0.032%이였다.

A rapid and simple determination of diazepam in intact diazepam tablets has been investigated using the near infrared spectroscopy(NIRS) combined with partial least squares regession. The separate calibration curves of 2 mg and 5 mg diazepam tablets were studied, as well as the linearity, concentration range and reproducibility of those calibration curves were evaluated. The correlation coefficients of calibration curves of 2 mg and 5 mg diazepam tablets are 0.9416 and 0.9159, respectively and the standard errors of calibration curves(SEC) are 0.018% and 0.032%, respectively.

키워드

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