Answer Posted / nikhil gandhi

Based on ICH Guideline there are many method given to
identify LOD and LOQ, but most useful method is slope and
residual standard deviation is used.

LOD : 3.3 X sigma/ Slope
LOQ : 10 X sigma/ Slope

Sigma : Residual Standard Deviation

2. Two grams of Benzoic acid are dissolved in 200 ml of water and extracted with 200 ml of diethyl ether. The distribution coefficient of benzoic acid is 100, and its dissociation constant is 6.5 10-5. Calculate the distribution ratio (D) of benzoic acid at pH 2, 5, and 6. 3. Calculate D at pH 2 to 10 (1 unit apart) in the above problem, and plot D versus pH.

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