Analytical Performace Parameters used for the purpose of Method Validation

Analytical Performace Parameters used for the purpose of Method Validation:

The following Analytical Performace Parameters are used for the purpose of Method Validation:

1) Accuracy

2) Precision

3) Linearity

4) Specificity

5) Detection Limit

6) Quantitation Limit

7) Sensitivity

8) Range

9) Robustness

10) Ruggedness

11) System Suitability

1) Accuracy: Accuracy refers to the closeness of test resulys obtained from an analytical method to the true value. The accuracy of a method must be determinex across its range of application.

2) Precision: Precision is defined as the degree of agreement among individual test results when the method is applied repeatedly to multiple samplings of a homogenous sample.

3) Linearity: Linearity is the ability of a method to generate results that are directly proportional to the concentration of analyte in samples across the method's range of application.

4) Specificity: Specificity is the ability of a method to assess unequivocally, the analyte in the presence of compounds expected to be present such as impurities, degradation products, other ingredients and other possible matrix interferences.

5) Detection Limit: Detection Limit is a characteristic applied to Limit tests and regers to the lowest amount of analyte in a sample that can be detected, but not necessarily quantitated.

6) Quantitation Limit: Quantitation Limit is a characteristic of quantitative assays for low levels of compounds in sample matrics, such as impurities and degradation products. It is the lowest amount of analyte in a sample that can be determined by the method with acceptable precision and accuracy.

7) Sensitivity: Sensitivity is the capacity of the procedure to record small variations in concentration. Limit of Detection & Limit of Determination are dependent on the sensitivity.

8) Range: Range of an analytical method is defined as the interval between the upper and lower levels of analyte that yield suitable precision, Accuracy and Linearity.

9) Robustness: Robustness is a measure of a method's capacity to remain unaffected by small but deliberate variations in procedural parameters.

10) Ruggedness:  The ruggedness of an analytical method is determined by analysis of the same samples by different analyst on different days using different lots of reagents. Each analyst prepared 6 samples of the same batch or lot to follow analytical assay method and calculate RDS value.

11) System Suitability: The accuracy and precision are the well behaved for the system suitability test.