Testing Method Robustness and Ruggedness

For a given number of analytical parameters (called factors in the original paper), there are two general options, one involving minimal designs, i.e. designs with 

SPE cartridges and the type of pre-packed commercial alumina cartridges used. Although the robustness evaluation was not planned using a multi-factorial method, the results were evaluated using simple analysis of variance (ANOVA, Section 8.2.6). 

The document describing the final method should include a cover page that includes a descriptive title and method identification, along with the name and address of the laboratory where the work was conducted. In many instances, an approval page that includes the names of the principal scientists and any other individuals who may have reviewed and/or approved the final method is provided along with their signatures and date that they signed the method. 

Every method should include an introductory section that describes the scope and applicability of the method. The scope should include (at a minimum) a brief description of the method including the analyte and matrix, LLOQ and range of reliable response. For methods that have been successfully validated, a reference to the validation report number or ID should be provided. Any revisions to the original method (if previously validated) should be listed along with a brief description of the revisions made and reference to any other validation studies that were conducted as a result of those revision. 

A written stepwise analytical procedure is a document that provides a detailed description of the extraction and analysis techniques used for validation (Chapter 10). If the method has been previously validated, the stepwise procedure will be a component of the final method or SOP. Many laboratories will in fact create a draft method 

---