Bioequivalence and Bioavailability Forum

Hari,

as in my practice for study sample analysis, the Average area of IS of all CC and QC will be calculated in MS EXCEL sheets.

Just calculate the 50% and 150% for the Average area of IS for CC and QC.

If your study sample IS area is falling out of +/- 50% area you need to identify as IS variation.
or near to LOQ samples if IS variation (is there but with in 50% +/-) perform repeat in Duplicate samples and conform.

For validation if 50% at each level QC and 67% for overall QC pass is sufficient.
if Any one or two runs have drastic variation is there and still the QC samples Pass as per the Area Ratio you can consider.

If frequently IS variation occurs in your method, Use the VALCO Valve.
Valco switching programme allows the Analyte and IS portion of chromatographic elution and So Curtain Plate will be neat.

Use Electonic multi pippette for Reagent or IS addition.


But if frequent IS variation where the Run sequence contain the BT stability or FT stability samples or recovery experiments where you compare the IS area with extracted IS area, your %CV will be not satisfactory.