고성능 액체크로마토그래프 기기의 성능검증을 위한 밸리데이션 가이드라인에 대한 연구

• 영문명: Investigation of Validation Guidelines for Performance Verification of High Performance Liquid Chromatograph
• 발행기관: 대한약학회
• 저자명: 윤원남 이범규 이원재
• 간행물 정보: 『약학회지』제57권 제5호 (2013년), 362~368쪽, 전체 7쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2013.10.31

영문 초록

High performance liquid chromatograph (HPLC) is the most frequently used analytical instrument in analytical laboratories for pharmaceutical analysis. In order to provide a high level of assurance for reliable data generated from the HPLC analysis, the performance qualification of the HPLC system is required. For this purpose, the performance of HPLC system should be regularly monitored by examining the key functions of the typical HPLC system (solvent delivery system, injector system, column oven, UV-VIS detector system). We have investigated the validation guidelines of the performance verification of these key modules for HPLC system. And we proposed and evaluated its validation guidelines and the related verification methods for pharmaceutical analysis that could be practically applied in Korea.

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키워드

high performance liquid chromatograph validation guideline performance verification