Method Development/Validation

[cody84]

Hey I was just wondering if anyone knows of a step-by-step guide/flow chart/decision tree or something like that to HPLC method development? I have the instrument experience, but am lacking in the chemistry department unfortunately. So far I've only had to validate methods with no-to little actual development. I also am aware of the books by Brenner etc, but cannot convince the company to buy them (yet). I basically do research on if there is a method already and use that as a starting point to develop/optimize my own for my finished products. However I'd like to learn or have a definitive guide (in one spot) on what to do based on the chemistry of the analyte.

Is there anything like this out there? It would also be useful eventually in implementing an SOP here for steps in method development. Obviously I couldn't write that, but just an idea.

[tom jupille]

Unfortunately, that's waaaaay to broad a topic to reduce down to a simple cookbook approach (if chromatography were that simple, there probably wouldn't be 78,000 posts on this Forum!).

A book is your best bet ($150 for a book is about half the price of a column!). The standard one is "Practical HPLC Method Development" by Snyder, Glajch, and Kirkland. Here's a link to it on Amazon:

http://tinyurl.com/3m7xchh

[LC_labrat]

I have gone to local universities to obtain journal articles, instead of using company resources, you might find the book there.

[cody84]

Haha, that's kind of what I figured, but thanks anyways!

[HiteshInamdar]

Hi
cody84 (nice name)

1. I would better suggest you to first of all go through the DMF method. This will give you the basic idea regarding drug and its behaviour.
2. Then by chaning the various parameters like buffer pH, mobile phase proportion, column temperature, column, etc. you can optimise your method. (But in this case, you have to have some basic knowledge of chemistry)
3. Then you have to check all the validation parameters to support your method.

Finally, If your method passes thorough all these hurdals then you can say ur method is fully developed