What is robustness in method validation, and how is it tested?

What is robustness in method validation, and how is it tested?

• A. Robustness is about instrument uptime.
• B. Robustness assesses method reliability under small deliberate changes in parameters (pH, temperature, flow, mobile-phase composition, column). It is tested by varying these parameters within small ranges and observing effects.
• C. Robustness is the same as accuracy.
• D. Robustness is tested by varying detector type.

Answer: (B)