sydney dating sydney - Validating chromatographic methods

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Green (11) gave a practical guide for analytical method validation, with a description of a set of minimum requirements for a method.

Renger and his colleagues (12) described the validation of a specific analytical procedure for the analysis of theophylline in a tablet using high-performance thin layer chromatography (HPTLC).

For example, if the method is to be run on a specific instrument in a specific laboratory, there is no need to use instruments from other vendors or to include other laboratories in the validation experiments.

In this way, the experiments can be limited to what is really necessary. Validation parameters for specific tasks The validation experiments should be carried out by an experienced analyst to avoid errors due to inexperience.

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.

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 validation procedure in this particular article is based on requirements for EU multistate registration.

Wegscheider (13) has published procedures for method validation with a special focus on calibration, recovery experiments, method comparison and investigation of ruggedness. (14) have described how analytical methods are validated in a Japanese QC laboratory.

Table 2 gives examples of which parameters might be tested for a particular analysis task.

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