Shimadzu CBM-20A - System Validation

7. Hardware Validation
7-12
CBM-20A/20Alite
7.6 System Validation
7.6.1 Validation of Isocratic LC System
 Objective
An analysis is performed and the retention time and peak area are obtained for each peak.
The data is then examined to check for reproducibility. Reproducible data validates the
system.
Generally, the system being validated consists of a minimum of the following components:
pump, column oven, autosampler, detector, system controller and data processor.
 Items Required for Validation
• The LC system is comprised of many individual components. System validation is used
to confirm the function of each component as well as the performance of the entire
system.
• The standard system validation procedure described in this section is used to
determine whether the LC system is functioning normally. This procedure constitutes
the basis of the LC system capability inspection.
• System validation is performed at installation, and periodically thereafter. If a problem
occurs during operation, system validation may be performed to determine whether the
problem is in the LC system or in the analysis method.
• If the LC system passes the system validation, it can be assumed that the LC system is
normal and that the problem lies in the particular analysis method or conditions being
used.
• If the LC system does not pass the system validation, it may be assumed that there is
an abnormality in the system, and component validation must be performed to identify
the malfunctioning component(s).
Item Description
Mobile phase
Mixture of water and methanol (3/2, v/v)
Both the water (distilled) and the methanol should be HPLC grade
Column
Shim-pack VP-ODS (Part No. S228-34937-91),
LUNA C18 (2) (Part No. 00F-4252-E0) or equivalent ODS column
(Particle size 5 µm, Column Dimension : I.D. 4.6 mm × length 150 mm)