What is use of LOD and LOQ in validtion and give range and in calculation why we

What is use of LOD and LOQ in validtion and give range and in calculation why we use 3.3* LOD here why we use 3.3

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What is use of LOD and LOQ in validtion and give range and in calculation why we use 3.3* LOD here w..

LOD is Limit of detection. We can dedect the peak but cant quantify
LOQ Limit od quaantification. We quantify also this is known as reporting thereshold.
During the RS analysis Below LOQ level we cant included in the total impurities calculation.
LOD and LOQ Determination three methods
1.S/N Ratio method
3 or 2 ratio for LOD
NLT 10 ratio for LOQ

2. Slope Method
Plot the linearity for active and impurities through serial dilution at lower level
Formula for LOD
3.3*Slope/Std.dev
Formula for LOQ
10*Slope/Std.Dev
3. Visualization method
It will be using for only identification and TLC Method

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What is use of LOD and LOQ in validtion and give range and in calculation why we use 3.3* LOD here w..

Answer / kovida

LOD and LOQ are the smallest amount of the particular compound that can by detected and quantiified by using the developed HPLC method.

The signal to noise ratio is that minimum amount which when injected in HPLC it gives minimum detectable peak area.

The value of amount at this point is multiplied by 3 to get LOD
and by 10 to get LOQ value. In short LOD is the thrice value of minimum value and LOQ is ten times of minimum value that can be injected in HPL

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