How to calculate LOD & LOQ in HPLC Validation Method
Answer Posted / bhupalreddy
Limit of Detection (LOD):
• Based on visual limitation
– Visual evaluation may be used for non-instrumental
methods but may also be used with instrumental methods.
– The detection limit is determined by the analysis
of samples with known concentrations of analyte and by
establishing the minimum level at which the analyte can be
reliably detected.
• Based on signal-to-noise
– This approach can only be applied to analytical
procedures which exhibit baseline noise.
– Determination of the signal-to-noise ratios is
performed by comparing measured signals from samples with
known low concentrations of analyte with those of blank
samples an establishing the minimum concentration at which
the analyte can be reliably detected. A signal-to-noise
ratio between 3 or 2:1 is generally considered acceptable
for estimating the detection limit.
• Based on the standard deviation of the response
and the slope
– The detection limit = 3.3 s / S
– Where s is the standard deviation of the response
and S is slope of the calibration curve.
– The estimate of S may be carried out in a variety
of ways, for example:
• Based on the standard deviation of the blank
• Based on the calibration curve
Limit of Quantification (LOQ):
• Based on visual limitation
– Visual evaluation may be used for non-instrumental
methods but may also be used with instrumental methods.
– The quantification limit is determined by the
analysis of samples with known concentrations of analyte
and by establishing the minimum level at which the analyte
can be quantified with acceptable accuracy and precision.
• Based on signal-to-noise
– This approach can only be applied to analytical
procedures which exhibit baseline noise.
– Determination of the signal-to-noise ratios is
performed by comparing measured signals from samples with
known low concentrations of analyte with those of blank
samples an establishing the minimum concentration at which
the analyte can be reliably quantified. A typical signal-to-
noise ratios is 10:1.
• Based on the standard deviation of the response
and the slope
– The quantification limit = 10s / S
– Where s is the standard deviation of the response
and S is slope of the calibration curve.
– The estimate of S may be carried out in a variety
of ways, for example:
• Based on the standard deviation of the blank
• Based on the calibration curve
| Is This Answer Correct ? | 21 Yes | 4 No |
Post New Answer View All Answers
if content uniformity passing but dissolution varrying then what is next step?
Why a1% value is used for some product ? What is the criteria for selection a1% value ?
Many times I don't got a caffeine peak in calibration of hplc using guard column ❓
What is diffrence between extractable volume and deliverable volume? Answer pls
How to choose the which salt is suitable for mobilephase
what is classification of elemental impurities? what is risk assement in elemental impurities?
what is mean by dissolution biowaiver study?
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.
WHAT IS THE PURPOSE WE USE HCL, CHOPPER, BURNER, MONOCHROMATOR in AAS? PLEASE EXPLAIN BRIEFLY
why we use Dichlorobenzene.nitrobezine.t-butyldi sulhate.for calibration of gc Head space
in monograph 7 imp are there but in vendor showing 5 imp do not req to include 2 imp for that what will be justification?
in each media we require to use SLS? how to proceed?
What is delay volume?
In the HPLC Calibration done wavelength accuracy done between 200nm-280nm .but not done remaining 300-400nm not done ?
How to do regeneration of Metacarb Pb plus column?