Browse > Article

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

Yun, Won Nam (College of Pharmacy, Chosun University)
Lee, Beom-Gyu (Department of Chemistry, Chosun University)
Lee, Wonjae (College of Pharmacy, Chosun University)
Publication Information
YAKHAK HOEJI / v.57, no.5, 2013 , pp. 362-368 More about this Journal
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
high performance liquid chromatograph; validation; guideline; performance verification;
Citations & Related Records
연도 인용수 순위
  • Reference
1 Watson, D. G. : Pharmaceutical Analysis, 2nd Edition, Elsevier, Toronto (2005).
2 Chan, C. C., Lam, H., Lee, Y. C. and Zhang, X.-M. : Analytical Method Validation and Instrument Performance Verification, John Wiley & Sons, New York (2004).
3 Huber, L. : Validation and Qualification in Analytical Laboratories, Interpharm Press, Buffalo Grove (1999).
4 Jin, J. Y., Kang, Y. K. and Lee, W. : The proposed validation guidelines and their application for performance verification of UV-VIS spectrophotometer. Yakhak Hoeji 50, 154 (2006).
5 European Directorate for the Quality of Medicines and Healthcare (EDQM) internet site; http://www.edqm.eu/en/ General-european-OMCL-network-46.html.
6 European Directorate for the Quality of Medicines and Healthcare, OMCL Network of the Council of Europe Quality Management Document, Qualification of Equipment Annex 1: Qualification of HPLC equipment, PA/PH/OMCL (2011).
7 Maldner, G. : Requirements and tests for HPLC apparatus and methods in pharmaceutical quality control. Chromatographia 28, 85 (1989).   DOI
8 Parriott, D. : Performance verification testing of high performance liquid chromatography equipment. LC-GC 12, 132 (1994).
9 Hall, G. and Dolan, J. W. : Performance qualification of LC systems. LCGC North America 20, 842 (2002).
10 Herman, L. : Performance verification of HPLC, Laboratory Focus-Gazette Edition (2002).
11 Wiggens, D. E. : System suitability in an optimized HPLC system. J. Liq. Chromatogra. 14, 3045 (1991).   DOI
12 Furman, W. B., Layoff, T. P. and Tetzlaff, R. F. : Validation of computerized liquid chromatographic systems. J. AOAC Inter. 77, 1314 (1994).
13 Grisanti, V. and Zachowski, E. J. : Operational and performance qualification. LCGC North America 20, 356 (1994).
14 Dionex Corporation; Operational Qualification/ Performance Qualification for HPLC Instruments (2008).
15 Agilent Technologies; Equipment Qualification Plan (2012).
16 Waters Corporation; HPLC Qualification Workbook (2011).
17 Shimadzu Ltd.; Shimadzu HPLC system Operational Qualification (2010).