% Recovery Calculation

GOOD VALIDATION PRACTICE (cGVP) LABORATORY, METHOD AND ANALYTICAL VALIDATION
1

Hi to all

I am starting assay by HPLC analytical method validation for our API product.

but i dont know how to get the %Recovery in Accuracy parameter.

plz can any one help in finding that.

plz explain me how to do the calculation to find the %recovery in accuracy parameter with an example

Rgds
Sri

2

[COLOR=“YellowGreen”]FOR FOR ACCURACY THERE ARE THREE APPROCH

  1. YOU CAN COMPARE THE METHOD WITH OTHER WELL ESTABLISHED METHOD WHICH IS ALREADY VALIDATED.

  2. SECOND APPROCH IS RECOVERY STUDIES

  3. LASTLY STATISTICAL APPROCH WHERE U HAVE TO FIND OUT SLOPE AND INTERCEPT OF WEIGHT OF SAMPLE VS AVERAGE AREA OF SAMPLE OF THREE DETERMINATION AT THREE CONCENTRATION.

THEN FIND OUT OBSERVED WT FOR EACH DETERMINATION BY FORMULA

AREA-INTERCEPT/SLOPE=OBSERVED WT

ACCURACY=OBSERVED WT/ACTUAL WTX100[/color]

3

Recovery exp is not to be performed for API validation