Is changing column robustness test or ruggedness test?

[moonchips]

what is the difference between robustness and ruggedness?

thanks a lot!

[Dan]

The definition of these terms is similar.

Ruggedness is the older term. It comes from the USP general information chapter on the validation of methods. You may not want to be using this term as it has been replaced by robustness from the ICH. (I don't have access to the USP right now to give its definition of ruggedness.)

ICH Q2 defines robustness as:

"The robustness of an analytical procedure is a measure of its capacity to remain unaffected by small, but deliberate variations in method parameters and provides an indication of its reliability during normal usage."

Q2 also states:

"In the case of liquid chromatography, examples of typical variations are:
- different columns (different lots and/or suppliers)"

Note that simply changing to a different column is not enough. You must use a column from another supplier or of a different lot.

Regards,
Dan

P.S. Link to ICH Q2: http://www.ich.org/LOB/media/MEDIA417.pdf

[syx]

Note that simply changing to a different column is not enough. You must use a column from another supplier or of a different lot.

If we want to use the procedure in routine analysis and we have certain column supplier it is not necessary to use column from different supplier or different column type from the same supplier in the ruggedness/robustness test unless we want to search alternate column. We could use different lot or age.