Definition of parameters of analaytical method validation

RANGE:

The range of an analytical procedure is the interval between the upper and lower concentration (amounts) of analyte in the sample where method is precise, accurate, and linear

                                                                                                    

SPECIFICITY:

Ability to measure desired analyte in a present component. These might include impurities, degradants, matrix, etc.

LINEARITY:

The ability to generate responses which are directly proportional to the concentration of an analyte in a sample

ACCURACY:

The accuracy of an analytical procedure expresses the closeness of agreement between the value

PRECISION:

The precision of an analytical procedure expresses the closeness of agreement (degree of scatter) between a series of measurements

Precision may be considered at two levels:

 Repeatability,

Intermediate precision.

Repeatability:

Repeatability expresses the precision under the same operating conditions over a short interval of time. Repeatability is also termed intra-assay precision .

Intermediate precision

Intermediate precision expresses within-laboratories variations: different days, different analysts, different equipment, etc.

DETECTION LIMIT :

The detection limit of an individual analytical procedure is the lowest amount of analyte in a sample which can be detected but not necessarily quantitated as an exact value.

QUANTITATION LIMIT :

The quantitation limit is the lowest amount of analyte in a sample which can be quantitatively determined with suitable precision and accuracy.

ROBUSTNESS:

The robustness of an analytical procedure is a measure of its capacity to remain unaffected by small, but deliberate variations in method parameters and provides an indication of its reliability during normal usage.