Specificity and precision for fasted state biorelevant media

NEW! Analysis

Specificity and precision testing helps confirm that your HPLC method is working reliably. This should be established before starting dissolution experiments.

During specificity and precision, the drug formulation and the biorelevant medium should be included to evaluate potential interference from excipients, biorelevant media components, and background peaks. It is also important to verify that the retention time, LOD, and LOQ remain within the in-house specification at both the beginning and end of the analytical sequence.

 

The following sequence is a typical example recommendation for assessing specificity and precision.


Sample Name (% drug)

No. of Vials

No. of Injections

Blank

1

5

Linearity Standard Lowest Concentration (5%)

1

5

Linearity Standard Highest Concentration (120%)

1

5

Working sample of Dosage form /Drug Formulation)

3

10 from each vial

Linearity Standard Lowest Concentration (5%)

Same vial

5

Linearity Standard Highest Concentration (120%)

Same vial

5


Check chromatographic properties do not change substantially during and at the end of the sequence

·         If system properties change, consider introducing washing cycles and/or a guard column

·         If chromatographic properties change, consider adjusting method, for example flow rate, temperature, injection volume, solvent ratios

·         If further adaptions are still required, consider broader modifications to the method, for example changing mobile phase, using a gradient or selecting a different stationary phase