PL-01-H01 · HPLC / UHPLC

HPLC & UHPLC: Selection, Qualification and Troubleshooting

Start with the decision, not the list of modules.

Comparing two systems, checking method suitability or investigating an abnormal chromatogram? Organise the evidence before changing settings. The HPLC/UHPLC pathway separates platform selection, performance checks, system preparation and diagnosis.

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A pathway for each type of problem.

The order of checks depends on the question. Start with documented conditions and history; retain the data and record changes before assessing the checks.

01

Selection & requirements

Compare HPLC and UHPLC against the actual methods. Turn pumping, injection, temperature control, detection and software capabilities into verifiable requirements.

  • HPLC vs UHPLC
  • URS and configuration

02

Qualification & controls

Separate individual module tests from evidence that the system is suitable for the method. Qualification does not remove the need for analytical sequence controls.

  • DQ, IQ, OQ and PQ
  • Calibration and system suitability

03

Columns & mobile phases

Consider the column, sample and mobile phase as parts of the same separation. Check compatibility, preparation, storage and usage history.

  • Columns and storage
  • Mobile phases and preparation

04

Chromatogram diagnosis

Define the symptom: pressure, peak shape, baseline or carryover. Compare conditions and perform targeted checks without accumulating uncontrolled changes.

  • High or unstable pressure
  • Tailing and split peaks
  • Noise, drift and carryover

05

Maintenance & transfer

Plan post-maintenance verification and assess the procedure when the configuration changes. Copying the recipe does not automatically reproduce the result.

  • Maintenance and return to use
  • HPLC–UHPLC method transfer

Prepare a case that can be assessed.

For a support request, gather the configuration, column, method, sample, reference chromatograms, problem onset and actions already taken. Do not send unnecessary personal or confidential information. Operating limits and safety instructions remain those of the approved procedure and the manufacturer’s manual.