Suitability test SOP for HPLC

[lzlugo]

Hello! I need help to do a homework. I need to write a Suitability Test SOP for HPLC to verify every HPLC parts and to confirm that everything is working correctly before conducting an analysis. Please give me some idea of how I can write it or where I can find information abou it. Thank You!.

[tom jupille]

First, can you give more information about the course you are taking, and what your level is, so that we know how to respond.

Second, do you want to verify each component of the system individually, or do you want to verify the system as a whole? (That's a hint, by the way! )

[lzlugo]

Thank You very much for your reply. Currently I am coursing my fourth year of Bachelor's Degree in Chemistry. I am taking an Industrial Chemistry course and the professor ask us to write a System Suitability Test SOP for HPLC and I found a lot of information about it, but I don't have an idea of how to start to write it.

Thank you for your help.

[lzlugo]

By the way I forgot to tell you that I want to verify the HPLC system as a whole.

[tom jupille]

The place to start is with the FDA Guidance on validation of chromatographic methods:
http://www.fda.gov/CDER/GUIDANCE/cmc3.pdf

The section on system suitability has suggestions from the FDA on what should be included. These are minimal suggestions; you can add any other parameters that you feel are justified (but you do have to justify them!).

[lzlugo]

Thank you for your reply it will be very helpful.