In dissolution test for Abilify 5mg (aripiprazole) Results show high results about 110%, while maximum result should not exceed 104%(max. result in content uniformity test).
This problem does not happened in Abilify 10 or 15 or 30mg.the different in Abilify 5mg is the colorant which is indigo carmine aluminum lake (E132).
When i run the dissolution test with placebo tablets (without active) it give results about 6%.
Dissolution medium contain KCL and 0.2N HCL. PH 1.2
The same method used for all types of Abilify tablets
UV- visible at 249nm , rpm 60 for 30 min.
So, if the reason is the colorant, how to avoid it?
hi Medhat Emad, I also worked on ablilify earlier. I didnot face such problem. I would suggest you to go for different wavelength where the colorant effect will be negligible. also I would like you to study your excipient in detail. And at last if nothing worked out then go for method change.
Determine absorbance of your samples using a blank solution made with the placebo of the formulation containing the lake colorant, to substract the effect of such colorant.
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