SOP for Verification of System Suitability Test : Pharmaceutical Guidelines

SOP for Verification of System Suitability Test

Standard operating procedure to verify system suitability software results Vs manually of the high Performance liquid chromatography for result accuracy.

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 of the high-performance liquid chromatography.

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 respective standard operating procedure of HPLC.
5.3 Prepare the mobile phase consisting of 70% methanol. : 30 % of water.
5.4 Prepare a mixture of 0.1 % Benzene and 0.1% Toluene in methanol.
5.5 Set flow rate at 1.0 ml/min.
5.6 Allow the system to be saturated with mobile phase for at least 15 minutes before injecting the test sample.
5.7 Record the area and retention time of both Benzene and Toluene in methanol.
5.8 Calculate the system suitability parameters with the help of software such as resolution, tailing factor and theoretical plate.
5.9 Now calculate the tailing factor, resolution and theoretical plate manually by 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 t= R.T of Ist components
              t2 = R.T of IInd components                
         w1 = Width of Ist components
          w= Width of IInd component  
Tailing :  T =  w/2f
Where  w = width of peak
            f  = width of half peak at 5 % height 
The performance of software of the instrument is satisfactory if the all the parameters of the system suitability test are within the acceptance criteria.

Related: Calculation of Relative Response Factor (RRF) in HPLC

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%)                   
3)  Theoretical Plate :      

     As per software =______________ 

     By manually  =    N = 16 (t/w)2
                                
                           = ------------------------ ( +/- 10%)
Remarks: Comply/Does not comply
Acceptance criteria :  Difference should be within +/- 10.0 %

6.0 ABBREVIATION

6.1 % = Percentage
6.2 ml = millilitre
6.3 RT = Retention time





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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