Hi, Im working comparative dissolution testing with amlodipine valsartan tablets. Currently I use test 1 dissolution method from USP43, when I do dissolution test, amlodipine dissolution Ok but when I do dissolution profile with sampling interval 10, 15, 30, 45 and 60 minutes, amlodipine never reach 80%. I thought maybe amlodipine decompose when contact with stainless steel paddle, but I already ask to USP, they told that amlodipine valsartan tablet use stainless steel paddle. Is there anyone can share with me experience for dissolution profile with amlodipine valsartan tablets?
Dissolution time is 30 min USP 43 if Amlodipine dissolution is ok then how it's possible that time interval dissolution not complies?
If you stop dissolution during intervals sample it may be the reasons other wise no reason if dissolution is ok.
Please look at the following below links which may help you in your analysis:
http://dissolutiontech.com/DTresour/201508Articles/DT201508_A05.pdf
https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/iras/amlodipine-and-valsartan-tablets.2017-09-21.pdf
https://www.scielo.br/j/bjps/a/cgQ3SJP9GJ58txM9cjgtCvw/?lang=en&format=pdf
Thanks
[Note—Use paddles covered with Teflon or made of any inert material except stainless steel.]
Hi Saeed, Im still confuse how could it happen. Dissolution profile for Exforge tablet also only 60-70% until 60 minutes.
Hi Mahmoud, thanks for your suggestion. Since there is no problem with dissolution test for 30 minutes and USP not stated teflon paddles for amlodipine & valsartan tablets, Im still refer to USP dissolution method
Hi, can you describe more detail the problems, my simple question: Have you validated your dissolution method according to ?
Hi Pak Gunawan, the method not yet validated. We still do formula optimization for tablet. Based on the USP 43 dissolution method test 1. If we do dissolution test for Exforge tablet and our formula, the dissolution result for Amlodipine is OK. But if we do dissolution profile (sampling interval 5, 10, 15, 30, 45 and 60 minutes) % dissolution for amlodipine only reach 60-70%. Thank you
OK, please read USP , regarding validation method of analysis for dissolution (whatever the formula is). I do not understand your problems. I can help you to solve the problems, but I need to now a little bit detail what you has done You can send via WA or E-mail.
Kindly Check...
https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/iras/amlodipine-and-valsartan-tablets.2017-09-21.pdf
Dear Febry
we had the same problem but it was not because of decomposition. You need to improve your tablet formulation.
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