1)why use benzophenon,uracil in hplc calibration.
2)why use sucrose in polarimeter calibration.
3)what is S/N ratio, noise and drift in hplc
4)how we can find lod and loq in method validation
Answer / sri krishna
1. URACIL & BENZOPHENONE are commonly available standards,
with simple mobile phase i.e acetonitrile & water they can
be separated, peak shape is good, retension time is very low.
2. Sucrose is optically active which shows linearity1. Very
Easily prepared, Has a fixed rotation value which can
calibrated with 10%, 20% and 30% sugar value, and remains
constant for those concentration for a little time only,
upto that we can have a very sharp reading calibration of
pure sugar, Mainly polarimeter is used sucrose quality
detection for calibration with pure sucrose is the best
deal, Its shows almost no Muta rotation,And last and
final...Its most cheap to figure out and get the calibration
done.
3. signal to noise ratio. where signal is the response of
the analyte and noise is the disturbance present in the base
line.drift is the slow increase/ decrease the base line.
4.LOD: BY 7.1. Based on Visual Evaluation
Visual evaluation may be used for non-instrumental methods
but may also be used with instrumental methods.
The quantitation limit is generally 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.
7.2. Based on Signal-to-Noise Approach
This approach can only be applied to analytical procedures
that exhibit baseline noise.
Determination of the signal-to-noise ratio is performed by
comparing measured signals from samples with known low
concentrations of analyte with those of blank samples and by
establishing the minimum concentration at which the analyte
can be reliably quantified. A typical signal-to-noise ratio
is 10:1.
7.3. Based on the Standard Deviation of the Response and the
Slope
The quantitation limit (QL) may be expressed as:
QL = 10 σ/S
where σ = the standard deviation of the response
S = the slope of the calibration curve
Is This Answer Correct ? | 14 Yes | 1 No |
If change in specification which parameter require to do for validation? if change in chromtographic condition then which parameter? if api change then which parameter? if change composition then which parameter? if old method not work out then whicj parameter? if additional one impurity added then which parameter of validation require to do on above each conditions? elaborate separately
why we are using 6 dosage units in dissolution, and why we are using 6 tablets in disintegation test.is there any scientific reason beyond 6?
What is Signal to noise ratio?
What is FDA form 482c?
What are the class-1 residual solvents listed in ICH guidelines?
What is NPOC method in TOC?
Why we use holmium oxide,perchloric acid for uv/vis calibration
4 Answers Cipla, Orchid, Ratiopharm,
What are the concentration limit for class-1 residual solvents in ICH ?
difference between pH & pOH ?
What is a base line?
What is Spliit and Splitless in Gas Chromatography nad How does it work?
what is a placebo peak
2 Answers GMP Pharma, Optimus,