Analytical Methods

Validation of Analytical Methods

Analytical methods are used for testing the qualitative properties of pharmaceuticals in laboratories. Depending on the type of analytical method used, such qualities as accuracy, precision, specificity, consistency, reproducibility, linearity, scope, stability, detection limit and quantitative limit are evaluated.

The aim of the validation of an analytical method is to provide documented proof that it is fit for purpose by verifying and documenting the evaluation of said characteristics of the analytical method.

We perform the validation of analytical methods with regard to:

Chromatographic methods

Spectroscopic methods

Electrochemical methods

Other

Sample Project

Subject

Validation of an analytical method using High Performance Liquid Chromatography (HPLC)
to identify the determination limit and the detection limit of the compounds included in the mixture.

Scope

What was validated was a new method of identification of the detection limit for a mixture of compounds by means of HPLC.

The first stage comprised defining the parameters to be tested and the acceptance criteria.

Then a plan of validation experiments was prepared and the characteristics of the equipment specified.

After the basic requirements were satisfied, samples of model materials and reagents necessary for the experiments were prepared.

Results of implementation

When the experiment was completed, the raw data was processed mathematically and all the parameters considered in the method validation were calculated:

  • Specificity/selectivity
  • Precision
  • Accuracy
  • Method scope
  • Linearity
  • Detection limit
  • Determination limit
  • Flexibility
The last stage included preparation of the SOP for the examinations to be carried out with the validated method, definition of the revalidation criteria, and creation of the validation report.

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