Bioequivalence and Bioavailability Forum

Dear Shweta,

❝ Dear sir,

We also have some Ladies visiting the forum. Don't discourage them from answering

❝ My question is it sufficient to carry out only one P&A batch?

❝ Isn't there need of caary over and more P&A experiment?

One P&A batch is not sufficient. You have decreased the LLOQ from 50 to 10 ng/ml. You have to show P&A at the LLOQ level, both within-run and between-run.

I think you also have to go for matrix effects again. API 3000 and 3200 have different ion sources (even if you have ESI on both instruments, the geometry of the source is different).

Carry-over: IMHO this depends more on your HPLC system (autoinjector, injection valve, tubing etc.) than on the MS/MS system you have afterwards.

Regards
Ohlbe