고시의약품 시험에 사용되는 유해시약 대체 시험법 개발

• 영문명: Development of Alternative Testing Methods without Hazardous Reagents used in Korean Pharmaceutical Codex
• 발행기관: 대한약학회
• 저자명: 김희연(Hee Yun Kim) 강현경(Hyun Kyung Kang) 최선희(Seon Hee Choi) 방수진(Su Jin Bang) 한경진(Kyung Jin Han) 최승희(Sung Hee Choi) 김진희(Jin Hee Kim) 이화정(Hwa Jung Lee) 강찬순(Chan Soon Kang)
• 간행물 정보: 『약학회지』제54권 제2호 (2010년), 142~149쪽, 전체 8쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2010.04.30

영문 초록

Development of alternative testing methods for the replacement of hazardous reagents with less hazardous ones is strongly enforced because exposure of human and environment to hazardous reagents are restricted and hazardous reagents are gradually prohibited from using in various testing methods. Thus, in this study, we developed 8 monographs from the Korean Pharmaceutical Codex by substituting the use of the hazardous reagents including ICH class 1 such as benzene, chloroform and dioxane to the use of less toxic ones like ICH class 2 or 3 reagents. We also improved their qualification and quantification performance. Among 8 monographs, the 6 newly developed TLC methods for the identification of nifedipine, oxolamine citrate, ketoprofen lysinate, chlorquinaldol, retinol acetate, and riboflavin showed a clear spot of corresponding material without any interference in spite of the replacement with ICH class 2 or 3 reagents. For the quantification of domperidone and trimebutine, HPLC methods were developed for the substitution of UV/VIS spectrometry and titrimetry, respectively. These HPLC methods were validated for the linearity, recovery, reproducibility, and inter-laboratory variations. In conclusion, the newly developed methods could be expected to become valuable tools for revising the Korean Pharmaceutical Codex.

키워드

Korean pharmaceutical codex hazardous reagents alternative testing methos