Practical High-Performance Liquid Chromatography (Meyer/Practical High-Performance Liquid Chromatography) || Appendix 2: How to Perform the Instrument Test

✍ Scribed by Meyer, Veronika R.

• Publisher: John Wiley & Sons, Ltd
• Year: 2010
• Tongue: English
• Weight: 449 KB
• Edition: 5
• Category: Article
• ISBN: 0470682183
• DOI: 10.1002/9780470688427.ch25

✦ Synopsis

The present operating procedure describes the procedure and the documentation for the performance qualification (PQ) of HPLC systems. 1 It can be used for both isocratic and gradient systems with UV detection and it is independent of the instrument manufacturer. The procedure includes the tests of pump, autosampler, UV detector and column oven. It can be put into practice immediately.

All the proposed setpoint values are well proven recommended data and can be adapted to the individual requirements.

For laboratories working in accordance to GLP or GMP it is recommended to perform the test after the installation of a new HPLC system, later at least once a year and in any case after a change of location. If a component (e.g. the pump) needs to be repaired the relevant part of the test should be performed again.

25.2 TEST SEQUENCE

The following sequence is recommended for an efficient test procedure:

(a) Preparation of the mobile phases including degassing. Priming of the system, preferably the day before the test.