Linearity vs Range
Analytical Method Validation
Linearity proves results are directly proportional to analyte concentration (a straight line on a graph),while
Range defines the concentration interval where the method reliably shows good precision, accuracy, and linearity, typically from low to high levels, ensuring fitness for purpose. Linearity is checked with calibration curves (𝑟2>0.995) and visual inspection, while the range confirms the method’s ability to measure accurately across expected sample variations.
(𝑟2>0.995) and visual inspection, while the range confirms the method’s ability to measure accurately across expected sample variations.In Linearity test a set of standard solutions containing the API at various concentrations e.g., 10%, 25%, 50%, 75%, 100%, 120% and 150 % of the target concentration is prepared.
The range of an analytical method typically includes the lowest and highest levels of the target analyte that the method is expected to measure accurately.
