I need advice on validating tablet dissolution method, specifically relating to the dissolution aspect rather than an associated UV or HPLC method.

Thanks.

What is your question? A lot will depend on where you are starting from. Do do have placebo's or matrix blanks? Do you have tablets of the final formulation? Do you already have validated assay and content uniformity methods?

Dear Tom,

The assay method has already been validated, but not the content uniformity. Placebo,tablets of the final formulation are available.
My question is how many factor (relating to the dissolution only) that I have to consider, how to perform the precision test (one dissolution with six vessels, or six dissolutions with total 36 vessels), if I have to take the individual tablet weight into consideration , what the accepted % RSD are.
Thanks

Sorry for the delay, feel free to contact me via e-mail. Assuming you will be analyzing the dissolution samples by HPLC you will need to perform; accuracy, precision, intermediate precision, specificiy (maybe), linearity, range, and robustness. I would perform the validation with active spiked placebo, six vessels is sufficient for precision, I do not take individual tablet weights into consideration. If you are going to filter your samples, make sure you do a filter binding study. We often use 5% RSD in our validation protocols for precision, but this depends on many factors. That is the easy part. The harder part is ensuring that the method is discriminating - picking dissolution media, paddle speed, end point (profile). The Dissolution Handbook by Hanson is a good reference. Good Luck.