Hello;
In an analytical Method validation whose intermediate precision was carried out by following the same analytical procedure (Assay of an API by HPLC) and by changing the day, the equipment, the analyst ...;
In our laboratory we carried out this criterion with the previous changes in addition we changed the column to another brand (we kept the same dimensions); the retention time changed more than 7 minutes (compared to the retention time obtained in repeatability) can I say that the intermediate precision is compliant (RSD of the 12 tests is less than 2%) and I accept this validation despite the fact that there is a variation over time in the retention of the main peak? After investigation the column is the cause of this variation.
Thank you in Advance
There is no specific answer to your question. It is up to you decide and evaluates the result. According to me the difference of 7 min is very much and it suggests that columns are not equivalent.
For intermediate precision, two changes are sufficient, a different day and different analysts.
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