Chromatography Forum

Hello.

What tests of an analytical validation do you perform?

Hi Danor,

I am not sure of your type of analysis, but in general method validation parameters of HPLC/IC/UHPLC methods cover the following areas:-

System Suitability Tests:-
• Capacity factor
• Precision/ Injection repeatability
• Relative retention
• Resolution
• Tailing factor
• Theoretical plate number

and:-
• Accuracy
• Detection Limit and Quantitation Limit
• Linearity
• Precision
• Repeatability
o Injection Repeatability
o Analysis Repeatability
o Intermediate Precision
o Reproducibility
• Range
• Recovery
• Robustness
• Sample Solution Stability
• Specificity / selectivity

I think that the original poster is asking about "verification" of compendial methods to use in his facility, which is different from validation requirements when developing a new method.

You and your QA should investigate and write up as an SOP, and then follow that. For example, when we set up trace ethylene glycol and diethylene glycol USP test for glycerin, we just followed the USP procedure as written, so only nominal testing was required.