Nondestructive Quantification of Intact Ambroxol Tablet using Near-infrared Spectroscopy

근적외분광분석법을 사용한 암브록솔 정제의 비파괴적 정량분석

  • 임현량 (동덕여자대학교 약학대학) ;
  • 우영아 (동덕여자대학교 약학대학) ;
  • 김도형 (동덕여자대학교 약학대학) ;
  • 김효진 (동덕여자대학교 약학대학) ;
  • 강신정 (식품의약품 안전청 마약시험과) ;
  • 최현철 (식품의약품 안전청 마약시험과) ;
  • 최한곤 (영남대학교 약학대학)
  • Published : 2004.02.01

Abstract

Near-infrared (NIR) spectroscopy was used to determine rapidly and nondestructively the content of ambroxol in intact ambroxol tablets containing 30 mg (12.5% m/m nominal concentration) by collecting NIR spectra in range 1100-1750 nm. The laboratory-made samples had 10.3∼15.9% m/m nominal ambroxol concentration. The measurements were made by reflection using a fiber-optic probe and calibration was carried out by partial least square regression (PLSR) with autoscaling. Model validation was performed by randomly splitting the data set into calibration and validation data set (7 samples as a calibration data set and 5 samples as a validation data set). The developed NIR method gave results comparable to the known values of tablets in a laboratorial manufacturing Process, standard error of calibration (SEC) and standard error of prediction (SEP) being 0.49% and 0.49% m/m respectively. The method showed good accuracy and repeatability NIR spectroscopic determination in intact tablets allowed the potential use of real time monitoring for a running production process.

Keywords

References

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