HPLC Separation Robustness and Ruggedness - Variables to Evaluate during Method Development
A rugged HPLC method is one that produces reproducible analytical results under actual use conditions.
To produce results that are accurate, repeatable, and reproducible an HPLC separation must either be relatively insensitive to small variations in analysis conditions, or those variations must be identified and controlled satisfactorily. This is termed method robustness. It is a required validation criterion for analytical methods submitted to national and international regulatory agencies.
In this presentation we will discuss:
Important factors that affect the robustness and ruggedness of HPLC separations
Describe the importance of and the advantages of considering these factors as part of the method development process
The development of a robust method is not only cost effective in the long term, but it also increases the likelihood of successful method transfer to other in-house or contract analytical laboratories.
Presenter: Rita Steed (Application Engineer, Agilent Technologies, Inc.)
Rita Steed began supporting the LC column line for Agilent in 1999. As a Chromatography Specialist (first with Chromatography, Inc., then directly for Agilent), Rita worked on-site with researchers in Pharmaceutical and other industries presenting technical seminars and assisting researchers with troubleshooting and method development. Rita has over 20 years of Chromatography experience in the Biotechnology, Chemical, and Pharmaceutical industries. She has held positions in Research, Sales, and Technical Service. Rita has earned degrees in Microbiology and Life Sciences/Biochemistry. In her current position, she is an inside Application Engineer supporting LC columns.
