Question

Difference between ruggedness and robustness in method validation

Answer 1

Answer:

The terms robustness and ruggedness refer to the ability of an analytical method to remain unaffected by small variations in method parameters (mobile phase composition, column age, column temperature, etc.) and influential environmental factors (room temperature, air humidity, etc.) and characterize its reliability during normal usage.

The notion of remaining unaffected by varying a method parameter has two possible interpretations – it can be interpreted as:

(a) no change of the detected amount of the analyte in a certain sample in spite of the variation of the method parameter or

(b) no change of the critical performance characteristics (e.g. limit of quantitation) by the variation of the method parameter.

In experimental evaluation of robustness either one of these interpretations can be used.

Robustness and ruggedness definitions in the guidelines as well as review articles are very similar. Some guidelines use the term robustness and some use ruggedness. When used together these terms are treated as synonyms in most cases.