Difference between robustness and ruggedness

What is the difference between robustness and ruggedness in analytical method validation

“Ruggedness” should be used as a parameter evaluating constancy of the results when external factors such as analyst, laboratory, instrument, reagents and days are varied.

“Robustness” should be used as a parameter characterizing the stability of the method with respect to variations of the internal factors of the method. This involves the parameters related to sample preparation, mobile phase composition, mobile phase flow rate, injection volume, column temperature etc. In addition, an important aspect of the robustness is the stability of the method against the variability of the sample matrix.
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.
Sometimes the terms Ruggedness and Robustness are used interchangeably.
The evaluation of robustness should be considered during the development phase and depends on the type of procedure under study. It should show the reliability of an analysis with respect to deliberate variations in method parameters. If measurements are susceptible to variations in analytical conditions, the analytical conditions should be suitably controlled or a precautionary statement should be included in the procedure. One consequence of the evaluation of robustness should be that a series of system suitability parameters (e.g., resolution test) is established to ensure that the validity of the analytical procedure is maintained whenever used.

Examples of typical variations are:

  • stability of analytical solutions;
  • extraction time.

In the case of liquid chromatography, examples of typical variations are:

  • influence of variations of pH in a mobile phase;
  • influence of variations in mobile phase composition;
  • different columns (different lots and/or suppliers);
  • temperature;
  • flow rate.

In the case of gas-chromatography, examples of typical variations are:

  • different columns (different lots and/or suppliers);
  • temperature;
  • flow rate.

Reference: - VALIDATION OF ANALYTICAL PROCEDURES: TEXT AND METHODOLOGY
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