SOP for Verification of System Suitability Test Measured by Chromcard Software for GC
1.0 OBJECTIVE
To Verify system suitability values manually v/s software.
2.0 SCOPE
This procedure is applicable to verify system suitability software results Vs manually Chrom card software of gas chromatograph.
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3.0 RESPONSIBILITY
3.1 Doing: Technical Assistant
3.2 Checking: Executive/ Manager
4.0 ACCOUNTABILITY
Head of the Department
5.0 PROCEDURE
5.1 Frequency: Once in 6 months.
5.2 Operate the instrument as per the respective standard operating procedure of GC.
5.3 For solution preparation and instrument condition follow the respective procedure of calibration of respective instruments.
5.4 Record the area and retention time of both Methanol and Ethanol.
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Calculate the system suitability parameters with the help of software such as resolution, tailing factor and theoretical plate.
5.5 Now calculate the tailing factor, resolution and theoretical plate manually by the following formula
Theoretical Plate : N = 16 (t/w)2
Where t = R.T of the component
w = width of the component
Resolution : 2(t2 – t1)/w1 + w2 Where t1 = R.T of Ist components
t2 = R.T of IInd components
w1 = Width of Ist components
w2 = Width of IInd component
Tailing : T = w/2f
Where w = width of peak
f = width of half peak at 5 % height
5.6 The performance of software of the instrument is satisfactory if the all the parameters of the system suitability test are within the acceptance criteria.
5.7 Acceptance criteria: Difference should be within +/- 10.0 %
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6.0 ABBREVIATION
6.1 % = Percentage
6.2 ml = millilitre
6.3 RT = Retention time
Verification of system suitability parameters
Name of software :___________
1) Resolution :
As per software = _________________
2 (t2 – t1)
By manually = R = ------------------
w1 + w2
= ----------------- ( +/- 10 %)
2) Tailing :
As per software = ________________
By manually = T = w/2f
= ------------------------( +/- 10%)
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3) Theoretical Plate :
As per software =______________
By manually = N = 16 (t/w)2
= ------------------------ ( +/- 10%)