It is not always necessary to validate all analytical parameters that are available for a specific technique.
For example, if the method is to be used for qualitative trace level analysis, there is no need to test and validate the method’s limit of quantitation, or the linearity, over the full dynamic range of the equipment.
Initial parameters should be chosen according to the analyst’s experience and best judgment.
Final parameters should be agreed between the lab or analytical chemist performing the validation and the lab or individual applying the method and users of the data to be generated by the method.
The preparation and execution should follow a validation protocol, preferably written in a step-by-step instruction format.
Possible steps for a complete method validation are listed in Table 1.
Table 2 gives examples of which parameters might be tested for a particular analysis task.
Special attention should be paid to those equipment characteristics that are critical for the method.
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The analyst should be very well versed in the technique and operation of the instrument.
Before an instrument is used to validate a method, its performance specifications should be verified using generic chemical standards.