고성능 액체크로마토그래프 기기의 성능검증을 위한밸리데이션 가이드라인에 대한 연구
High performance liquid chromatograph (HPLC) is the most frequently used analytical instrument in analyticallaboratories for pharmaceutical analysis. In order to provide a high level of assurance for reliable data generated from theHPLC analysis, the performance qualification of the HPLC system is r...
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| Published in | Yaghag-hoi-ji pp. 362 - 368 |
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| Main Authors | , , |
| Format | Journal Article |
| Language | Korean |
| Published |
대한약학회
01.10.2013
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| Subjects | |
| Online Access | Get full text |
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| Summary: | High performance liquid chromatograph (HPLC) is the most frequently used analytical instrument in analyticallaboratories for pharmaceutical analysis. In order to provide a high level of assurance for reliable data generated from theHPLC analysis, the performance qualification of the HPLC system is required. For this purpose, the performance of HPLCsystem 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 performanceverification of these key modules for HPLC system. And we proposed and evaluated its validation guidelines and the relatedverification methods for pharmaceutical analysis that could be practically applied in Korea. KCI Citation Count: 0 |
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| Bibliography: | G704-000392.2013.57.5.007 |
| ISSN: | 0377-9556 2383-9457 |