Chromatography Forum

I have an old method for Dissolution testing with the aid of UPLC. The dissolution testing condition is different from what is stated on the products official USP monograph. Can I still apply the UPLC method of percent dissolved determination given that it was validated on different specs and disso conditions and not on what was stated on the verified HPLC method on the official USP monograph? Thanks.

Easy answer: What does your SOP say?

Seriously, I assume you're doing some kind of Pharma QC of that product? So certain product specifications and a validated method are part of the product's technical dossier and registered to the relevant authorities. Just stick to that method and that specifications, no need (and no permit) to change to a completely different method and different specifications.