Chromatography Forum

Hi all,

I am developing a HPLC method for impurities in Syrup which has lot of excipients which interferes with my impurity peaks. I tried with different ways but i coulnot eliminate that. Can anyone help me that whether i can go with GC for impurity method. If it is ok the method is stability indicating?

Thanks in advance

Hi
You must check again formula of your impurity.
GC reply for impurites that are volatile(boiling point under 350'C) and impurities that don't decomposed in heat.
but if your impurity is DMF or DMA or like it GC can help you,for more information please give us impurities name that you need analysis that.
Good Luck .

Hi

Generally speaking, if you can not chromatographicly resolve all impurities of intrest, it is not unheard of that an additional procedure have to be used for a drug product or drug substance for that matter.

Similary for stability analysis it likewise not unheard of that one procedure is used for release testing and addtional test are done for stability analysis.

Consequently it may be accepteble to use a different technique for resloving specific impurities that coelute on the "general procedure".