Accuracy Test for Extended Release Tablet (Dissolution)

[jayroseville58]

How to demonstrate an accuracy test for Extended Release Tablet (Dissolution)? It was mentioned that it can be demonstrated by specifying a range to be used. The lower value is NMT 20% (after 1 hour) and the upper value is NLT 85% (after 20 hours) so it means that I have to use a range of 0% to 105% if I am going to follow the ICH guideline (+/- 20% for Disso). But one more question is, how should I prepare a spiked sample. Is it right that I have to prepare it by spiking a placebo from 0% to 105% but the only sampling time to be considered is after 20 hours? Thanks.

[danko]

If the goal of your accuracy determination/documentation is to show the accuracy of your measurements - i.e. how accurate the HPLC part is, then 20 hours would be just fine.
But if I’m right, you need to document the dissolution part of the process as well. That implies the release dynamics as well. In such a case even spiking is inadequate. I’d get the formulation people to produce some tablets containing API at different levels and then determine the content at the desired time points. It goes without saying that after 20 hours (or later) all (maybe 3 different strengths) of the tested variants shout result in 100% recovery – plus/minus something of course.

Best Regards