YAKHAK HOEJI (약학회지)

The Pharmaceutical Society of Korea (대한약학회)
권호 표지

Investigation of Validation Guidelines for Performance Verification of High Performance Liquid Chromatograph

고성능 액체크로마토그래프 기기의 성능검증을 위한 밸리데이션 가이드라인에 대한 연구

  • Received : 2013.08.27
  • Accepted : 2013.10.22
  • Published : 2013.10.31
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Abstract

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.

Keywords

References

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