Should we first degrade the sample with respective degrading reagents and then extract the drug, or first extract the drug which is then subjected todegradatio?"
For example, is it preferable to first treat with acid and then extract the drug, or first extract the drug and then degrade with acid?
Dear; First you should investigate the impact of stress conditions on PURE AUTHENTIC material. The quick and dirt experiment should first tried, ex: Make thin film of pure material on glass dish, subject this powder to UV light (5 cm distance) and observe the color change, if changed, then your material is suspected to be light sensitive. second; pure sample + small vial --> to hot plate, just melt and change color, then dissolve in a solvent, inject for LC-UV or MS, observe the results. If you get separation, then try to develop your method using this samples for best separation.
Now, go systematically, and investigate the effect of ALL stress conditions as cited in ICH or FDA guidelines, start applying mild stress conditions not sever stress (ex; use 0.1M HCl, then, 1M HCl, then boil with 0.1M HCl,)
You are not allowed to show degradation more than 20% (i.e more than 10% of the drug losses is acceptable).
Dear Khedr,
Good morning. Thank you very much for your suggestion. But i want to know the process to start in formulation dosages. In formulations, what i have to do,i.e first i have to extract the drug then apply the degradation condition or i have to degrade first then extract my substance. I am not working with Pure active materials. Please.
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