Chromatography Forum

First question :

The validation of an analytical method needs the determination of Intra day precision , i should work for : three successive days or it is not important , i can take for example day 1, day 3 and day 6.

Second question

The validation of a bioanalytical method (biochemistry lab), what is the best way for validation
1-Classical method (linearity, accuracy, precision ,.....
2-validation of analytical methods based on accuracy profiles

Thank you

Hi,
answering your first question:
Day 1, 3, or 6 does not matter at all the only thing you should be aware of is that your analysis should be carried out using the same batch of the sample. I mean if your are working on a finished product batch number 0001 you should use the same batch on day 3 or 6.

For your second question regarding bioanalytic methods there is a detailed information in the Ph. Eur.
But can you give us an example of the method you want to validate?

Are you really meaning INTRA-day precision or rather INTER-day precision? For intra-day precision (repeatability) you don't have to worry about different days as it's meant to be done on one day .

I mean INTER-day precision