Validating chromatographic methods

Table 2 gives examples of which parameters might be tested for a particular analysis task.The scope of the method should also include the different types of equipment and the locations where the method will be run.This proposed procedure assumes that the instrument has been selected and the method has been developed.It meets criteria such as ease of use; ability to be automated and to be controlled by computer systems; costs per analysis; sample throughput; turnaround time; and environmental, health and safety requirements.Satisfactory results for a method can be obtained only with equipment that is performing well.Special attention should be paid to those equipment characteristics that are critical for the method.Representatives of the pharmaceutical and chemical industry have published papers on the validation of analytical methods.Hokanson (9,10) applied the life cycle approach, developed for computerized systems, to the validation and revalidation of methods.

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.For example, if detection limit is critical for a specific method, the instrument’s specification for baseline noise and, for certain detectors, the response to specified compounds should be verified.Any chemicals used to determine critical validation parameters, such as reagents and reference standards, should be Any other materials and consumables, for example, chromatographic columns, should be new and be qualified to meet the column’s performance criteria .The AOAC (15) has developed a Peer-Verified Methods validation program with detailed guidelines on exactly which parameters should be validated.Winslow and Meyer (16) recommend the definition and application of a master plan for validating analytical methods. Breaux and colleagues have published a study on analytical methods development and validation (17).

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