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KMID : 0370220130570050362
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Yakhak Hoeji
2013 Volume.57 No. 5 p.362 ~ p.368
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Investigation of Validation Guidelines for Performance Verification of High Performance Liquid Chromatograph
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Yun Won-Nam
Lee Beom-Gyu
Lee Won-Jae
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Abstract
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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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KEYWORD
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high performance liquid chromatograph, validation, guideline, performance verification
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