Validation of liquid chromatography mass spectrometry (LC-MS) methods

Glossary

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Recovery

The recovery of an analyte in an assay is the detector response obtained from an amount of the analyte added to and extracted from the biological matrix, compared to the detector response obtained for the true concentration of the analyte in solvent. Recovery pertains to the extraction efficiency of an analytical method within the limits of variability.

Repeatability

Expresses the closeness of the results obtained with the same sample using the same measurement procedure, same operators, same measuring system, same operating conditions and same location over a short period of time.

Reproducibility

Expresses the precision between measurement results obtained at different laboratories.

Residual

The difference between experimental signal and signal calculated according to the calibration function.

Robustness

A parameter used to evaluate constancy of the results to variations of the internal factors of the method such as sample preparation, mobile phase composition, mobile phase flow rate, injection volume, column temperature etc.

Ruggedness

A parameter used to evaluate constancy of the results when external factors such as analyst, laboratory, instrument, reagents and days are varied.

Run

See: analytical run