Abstract Quantitation and validation are key parameters in quantitative analytical methods. A definition of validation is: 'Validation is the procedure used to prove that a test method consistently yields what it is expected and required to do with adequate accuracy and precision'.
Validation should involve:
· Determination of the parameters that should be involved in the validation (e.g., accuracy, precision, linear dynamic range);
· Analysis of unknown samples (unknown concentrations) to determine the accuracy and precision;
· Equivalence testing, a comparison with existing methods should be made;
· Collaborative testing, to determine the ruggedness of the method.
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