By Anonymous on Thursday, July 10, 2003 - 07:46 am:
Dear All,
We manufacturing tablets of Fat soluble vitamins (single vitamin only). My problems is when we analysed lubricated granules assay were 100% and when we analysed compressed tablets assay comes to 80% what could be the reason ? In addition to this we analyse our product by HPLC method and method is validated. During method validation recovery passes the acceptance criteria of recovery from tablets not less than 98%.
By Anonymous on Thursday, July 10, 2003 - 10:33 pm:
Did you validate your method only for lubricated granules?
If so, your sample matrix has changed and you need to change and re-validate (at least accuracy) the method.
Sounds like your extraction isn't efficient enough for compressed tablets?
Are you extracting or dissolving the whole sample? If extracting, you can test incomplete extraction by second extraction of the same sample.
By Anonymous on Friday, July 11, 2003 - 06:33 am:
Thanks for your advice.
Lubricated granules on compression it becomes tablets than how matrix will change ?
We crashed 20 tablets and part of the sample take for assay purpose. Whole content of powder does not dissolved in solvent but active (Vitamin) is very soluble in solvent.As far as extraction concerend we did the same experiment which you have sugessted and it was found that in first extraction recovery was 100% during method validation so we are confident about extraction of active.
Our process is like this one is triturate which is very fine and contain active (Vitamin), made from oil based and another granules is aqueous based which is bigger in particle size compare to triturate. we trying to mix this granules with the help of lubrication. At lubrication stage as I said it gives satisfactory result 100% as it goes for compression stage and tablets assay comes to 80%.
I would like to known is it possible during compression fines may loss ?