HPLC Performance Qualification

**itung23** · 07-03-2012, 07:23 AM

Now, I am writing PQ protocol for HPLC Shimadzu LC-20 AB gradient system

IQ and OQ are done.

I confused about the parameter and acceptance criteria,

What parameter and guideline for this HPLC PQ?

**arzakan** · 12-19-2012, 05:15 AM

Hello everyone.I want to perform validation procedure for HPLC Waters 2695.Everything is clear for me for autosampler and detector part.I confused only with separation part.What substances will be better to use for that part?

**itung23** · 12-20-2012, 12:50 AM

Dear, arzakan

In my lab I have HPLC waters 2707...

I performed Performance Qualification of HPLC refer to QUALIFICATION OF EQUIPMENT
ANNEX 1: QUALIFICATION OF HPLC EQUIPMENT (http://www.edqm.eu/site/UPDATED_Anne...-en-832-2.html
by checking parameter:
1. Flow Rate Accuracy
2. Injection Volume Precision
3. Flowrate Precision
4. Carryover
5. Linearity (by volume and by concentration)

I checked all parameter using Caffein USP in water solvent

Can you explain more about what you said "I confused only with separation part" ? I don't understand what you mean

**arzakan** · 12-20-2012, 06:38 AM

Dear, itung23

Thanks for information.
As I saw you performed PQ with Caffein USP in water solvent.In our equipment I find that it was qualified at Alliance with Acetone, Acetophenone, Propiophenone, Butyrophenone.They gave different peaks.I think that I can perform PQ in the same type.

**itung23** · 12-28-2012, 01:28 AM

Dear, Arzakan

Actually, I didn't perform separation process on my PQ of HPLC because it is not mention in ANNEX 1: QUALIFICATION OF HPLC EQUIPMENT

I think separation parameter like that is optional parameter

Yes, I think you can perform separation parameter like it was qualified before

Good Luck