근적외선분광분석법을 사용한 암브록솔 정제의 비파괴적 정량분석

• 영문명: Nondestructive Quantification of Intact Ambroxol Tablet using Near-infrared Spectroscopy
• 발행기관: 대한약학회
• 저자명: 임현량(Hun Rang Lim) 우영아(Young Ah Woo) 김도형(Do Hyung Kim) 김효진(Hyo Jin Kim) 강신정(Shin Jung Kang) 최현철(Hyun Chul Choi) 최한곤(Han Gon Choi)
• 간행물 정보: 『약학회지』제48권 제1호 (2004년), 60~64쪽, 전체 5쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2004.02.28

영문 초록

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.

키워드

near-infrared spectroscopy intact tablet partial least square regression.