Skip to main content

SOP for Linearity Check of High Performance Liquid Chromatograph (HPLC)

SOP for Linearity Check of High Performance Liquid Chromatography (HPLC)
Standard operating procedure to check performance of the high performance liquid chromatograph (HPLC) for accurate results.

 1.0 Objective
To check the performance of the equipment for reliable and accurate results.

2.0 Scope
This procedure is applicable to check the performance of                                                                             the high-performance liquid chromatography.

3.0 Responsibility
3.1 Doing: Technical Assistant/Executive
3.2 Checking: Executive /Manager


4.0 Accountability
Head of the Department

5.0 Procedure
5.1 Operate the instrument as per the respective standard operating procedure of HPLC.
5.4 Instrument Performance ( Linearity of Results)
      Frequency: Two months.
5.4.1 Prepare the mobile phase consisting of 70% Methanol: 30 % water.
5.4.1 Stock solution preparation: Prepare a mixture of 0.2 % Benzene and 0.2 % Toluene in methanol.
5.4.2 Make dilution in the following manner.
5.4.1 Take 5 ml, 10 ml, 15 ml, 20 ml of stock solution respectively in 25 ml of volumetric solution                and makeup with methanol.
5.4.3 Set flow rate at 1.0 ml/min.
5.4.4 Allow the system to be saturated with mobile phase for at least 15 minutes before injecting the           different solutions.
5.4.5 Record the area and retention time of both benzene and toluene as per Annexure - I.
5.4.6 Calculate the Linearity for both Benzene and Toluene respectively.

6.0 ABBREVIATION
6.1 SOP - Standard Operating Procedure

ANNEXURE-I
Q. C. Department
LINEARITY CHECK REPORT OF HIGH-PERFORMANCE LIQUID CHROMATOGRAPH

PERFORMANCE DATE
DATE OF LAST PERFORMANCE DONE
NEXT DUE FOR PERFORMANCE



INSTRUMENT DETAILS
INSTRUMENT NAME
INSTRUMENT MAKE
INSTRUMENT IDENTIFICATION NO.



OBSERVATION    
1) Instrument performance ( Linearity of results)
Stock solution preparation :
Mixture of 0.2 % Benzene and 0.2 % Toluene in Methanol.
Solution 1) : 5.0 ml of Stock solution                   25 ml with methanol.
Solution 2) : 10.0 ml of Stock solution                 25 ml with methanol.
Solution 3) : 15.0 ml of Stock solution                 25 ml with methanol.
Solution 4) : 20.0 ml of Stock solution                 25 ml with methanol.
Solution 5) : Direct stock solution.

HPLC Parameter :
Column                  : ODS (25 cm X 4.6 mm, 5 μ)
Mobile phase         : Methanol : Water
                                            70 : 30
Flow rate                : 1.0ml/min.
Wave length           : At 254 nm
Solution No.
Conc.
Inj. No.
Bin No.
Area of Benzene
Area of Toluene
1
0.04%
1





2



2
0.08%
1





2



3
0.12%
1





2



4
0.16%
1





2



5
0.20%
1





2



Linearity : (Limit NLT 99.95%)


Labels:

Comments

Post a Comment

If you have any doubts, please let me know

Popular posts from this blog

Checklist for Audit in Sterile Area

Checklist for Audit in Sterile Area Checklist to verify the sterile manufacturing area before the audit. 1. Is there any SOP giving details for activity/ movement in the sterile area. 2. Verify the suitability of system for sanitization of hands. 3. Is there the SOP on entry-exit; gowning and de-gowning into the critical area available? 4. Verify the availability of following records:  Air pressure differential  Particulate monitoring  Temperature  Humidity  Microbiological monitoring by settle plate 5. Are these records available and maintained as per SOPs? 6. Check the above mentioned individual records. Are the entries within specifications mentioned in SOP/ MTPs. 7. Is the controlled copy of MTP pertaining to monitoring by settle plate available to plant person? 8. Are the location for settle plates identified and the chart/ layout available with plant? 9. Are the following areas monitored for parameters mentioned in step 4:  Air-lock to the critical ar...
Post a Comment
Read more

Aseptic Filling Process (Media Fill) Validation Protocol in Sterile Pharmaceuticals

Aseptic Filling Process (Media Fill) Validation Protocol in Sterile Pharmaceuticals Validation of sterile manufacturing process by media fill validation test as per PICS guidelines for aseptic validation or aseptic process simulation. 1.0 OBJECTIVE 1.1 To define procedures for validating and maintaining the validation of all aseptic filling processes and qualification of the quality of the product by system/facility/equipment. 2.0 SCOPE 2.1 This procedure applies to all aseptically filled sterile products intended for human use. 3.0 RESPONSIBILITY 3.1 The Validation personnel coordinate the aseptic filling validation program and write the sterile media aseptic filling processes reports. 3.2 Manufacturing personnel the sterile media aseptic filling processes and performs the sterile media fills. 3.3 QA personnel perform the sampling and assist with the IPQA monitoring required for each sterile media fill. 3.4 QC personnel to perform the testing and assist with the monitoring required fo...
Post a Comment
Read more

Blow Fill Seal (BFS) and Form Fill Seal (FFS) Technology in Sterile Manufacturing

Blow Fill Seal (BFS) and Form Fill Seal (FFS) Technology in Sterile Manufacturing Know about sterile pharmaceutical production using Blow Fill Seal (BFS) and Form Fill Seal (FFS) technology. Both of these techniques are used to manufacture  sterile pharmaceutical products   as parenteral (LVP & SVP), infusions, ophthalmic and inhalation products. These are automated techniques to prepare sterile products. The basic concept of the  FFS   and BFS is to reduce the  contamination   by forming the container, filling and sealing in a closed sterile chamber of the machine. There is no personnel intervention to reduce the chances of the contamination during the manufacturing of sterile products. It gives more production at very low operational cost with the high assurance of  sterility . Blow fill seal technology is widely used and accepted by the various pharmaceutical regulatory authorities as US-FDA and MHRA. The system is being used for over 30 years a...
Post a Comment
Read more