Chromatography Forum

Hi All

We have and old GC method that uses a Poropak T column.
We have recently changed the method to a Poropak Q column. What validation parameters should we do?
Thanks
Mike

Mike,

I am not going to ask you why you felt you had to change a validated method as you must have had reasons to spend money and time which justified making the change.

You have not told us anything about your method. It is used for sewage analysis? Drugs? Medical testing?

Whatever known analytes you were separating on the 'T' column should be shown to separate on the Q column.

You should also demonstrate that whatever you are measuring does not coelute with something else unknown on the Q where on the T column it was separated.

The reproducibility of analysis over the range of your measurement should be confirmed.

You should meet any requirements of regulatory agencies who oversees the business in which you are involved.

best wishes,

Rod

Hi Rod

The method is used to analyse ethanol content in an extract. Since we are working in the pharmaceutical industry we will have to revalidate this method using the new column. Thanks for your comments Rod.

Thanks
Mike