Chromatography Forum

I am doing some method validation for a HPLC Method.

The method in question has been validated for a different product within our range.

We now have another product with different excipients and manufacturing process, but with the same ACTICE ingredients at same amounts as this old product.

DO I NEED TO DO A FULL VALIDATION -- INCLUDING PRECISION, ACCURACY, and SPECIFICITY...ETC?

Or can I get away with just doing Specificity to prove that the excipiets are not affecting the actives and then refer to other validation?

Thanks in advance

Hi dwalker

You have to perform a full validation, which includes all parameters excepted the linearity.

Specifity, because you have a new matrix

Accuracy, because you have to proof the efficiency of extraction and the recovery

Precision, because you have to proof an acceptable precision (combination with recovery). Also intermediate presision has to be performed with your new samples.

LOD / LOQ is performed most authentically when you use placebo; therefore you cannot transfer the results of the old method to your new one.

Robustness should also be performed regarding specificity when varying several parameters. The shelf life of the standard solution is already determined (old product), but you have to determine the shelf life of the sample solution

Regards
Florian

Thank you so much for your detailed response.

Your explainations confirm what I was thinking, but I was hoping I might able to save some time.

You have saved me some reading though!

Thanks again

Dave