Method Validation

Robustness

Robustness is a term that is commonly used in publications dealing with method validation. Robustness testing deals with the critical operational parameters and the tolerances for their control. Robustness is the capacity of a method to remain unaffected by deliberate variations in method parameters. In the case of trace analysis using ICP, parameters such as:

• temperature (laboratory and spray chamber)
• concentration of reagents
• RF power
• nebulizer, spray chamber, and torch design
• torch height
• sampler and skimmer cone design
• sampler and skimmer cone construction material
• integration time
• detector design
• reaction/collision cell type or conditions
• resolution capability

These are all examples of parameters that could be easily altered, either intentionally or unintentionally, that could significantly affect the reliability of the determination. The fact that many procedures specify operational parameters or accessory designs/types is a result of robustness testing where the developing laboratory recognizes that critical parameters must be identified, specified, and controlled for the measurement procedure to be used reliably.

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