Bioequivalence and Bioavailability Forum

Dear Mr. Kumar,

Stabilization/equilibration is not an absolute requirement for Assay. As already explained in my previous post, the purpose of system stabilization is to handle the back pressure that is created in the system. If there is no increased back pressure the there would be no requirement for Stabilization/equilibration and one can proceed for assay of samples directly.

In order to mitigate this issue of misuse of samples, there should be a documented procedure for the same. An SOP should be in place specifying the preparation of samples. Generally aqueous based (Unextracted samples) samples are used for the same. In no case subjects samples be used for Stabilization/equilibration.

There is not totally fool proof strategy for handling the back pressure. This also depends on the column, the mobile phase etc.The mobile phase may be filtered through .22 micron filter to remove the complexes (if any). Also column washing may help mitigate the issue in case the column is completely blocked.

As far as I am concerned back pressure can be minimized but cannot be totally eliminated.

Regards
P.S.Srinivas