acceptance criteria for ph meter, hplc
detector,pump,injector,oven when we calibrate.
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Acceptance Criteria
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pH Meter:
-----------
Perform 2 point or 3 point calibration as per the
use/requirement.
The slope should be 95% to 105%
Where as pH measured value for known pH buffer should be
4.01 ± 0.05
7.00 ± 0.05
9.21 ± 0.05
10.00 ± 0.05
11.00 ± 0.05
HPLC Detector:
--------------
Prepare differenct concentration of caffeine solution say
10 ppm, 25 ppm, 50 ppm, 75 ppm, 100 ppm, and 125 ppm.
Inject single injection of each solution and calculate the
correlation coefficient = sholud be 0.999
HPLC Pump:
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a) Flow rate accuracy
b) GPV
a) Flow rate accuracy:
Calculate flow rate accuracy using water at difference flow
rate at 0.5 mL/min , 1.0 mL/min, and 3.0 mL/min at duration
of 5 minutes and calculate the volume collected with in 5
minutes duration using stop watch collected in pre-weigh
calss A volumetric flask.Apply density of water at
specified temperature.
Acceptance Criteria: For all the flow rate should be ± 5%
b) Gradient Proportianating Value (GPV)
GPV test will be perform using 5.6 mg of Propyl paraben ----
-} 1000 mL of methanol for channel A and B if we are
calibrating the Quadranaery pump and C and D channels in
methanol run the gradient composition at the specified time
to obtain the response when compared with higest response
of methanol vs propyl paraben solution should be 10 ± 0.5
i.e 9.5 - 10.5.
We can even calibrate using 0.5% Acetone in water by
evaluating the response obtained throughout the run time.
Injector:
---------
a) Injector Linearity
b) Injector precision
c) Volume accuracy
a) Injector Linearity
Inject singe injection of 25ppm caffeine solution of
injection volume 5µ, 10µ, 20µ, 50µ and 100µ. if the
injector loop is 100 µl loop where as if the injector loop
is 200 µl then go upto 200 µl for better accuracy.
Acceptance criteria: Correlation coefficient: 0.999
b) Injector Precision:
Inject 5 times of 25 ppm caffeine solution and calculate
the RSD for area.
Accetance criteria: < 1.0%
c) Volume Accuracy:
Check the injector volume accuracy by intecting the 5µl
volume for 10 times in a pre-weigh vial containing water.
Check the injector volume accuracy by intecting the 10µl
volume for 10 times in a pre-weigh vial containing water.
Acceptance criteria: 4.95 - 5.05 µl
19.5 - 20.5 µl
Column Oven:
------------
Calibrate the column oven with calibrated
thermometer/digital at 30° C and 70°C
Acceptance Criteria: 30 ± 2 °C
70 ± 2 °C
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