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Formulation analytical method development

Aim:

The aim is to set up a method to determine quantitatively the achieved concentration of the test item in animal dosing formulations by a GLP-conform validated method.

Method:

HPLC with UV detection is used for test items, which possess UV absorbance. For formulations at very low concentration of the test item or test items’ not showing sufficient UV absorbance LC/MS/MS is applied.

Procedure:

Solutions or suspensions for intravenous or extravascular application are processed by a simple sample preparation step and analyzed. Calibrators are measured in the same analytical run and used for the calculation of the achieved concentration. Blank samples and a sample of the test item prepared by independent weighing (QC sample) serve system selectivity, accuracy and precision.

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