Analytical Method Validation

Analytical Method Validation:

Analytical Method Validation is a process of proving that an analytical method is acceptable for its intended purpose.

Parameters of Analytical Method validation:

1. Specificity: Specificity is the capability of an analytical method to to clearly define the analyte in the presence of components which may be expected to be present.
2. Accuracy: It relates to the closeness of the test results to true value i.e. measure of exactness of analytical method. It is expressed as % recovery by the assay of known/added amount of analyte in the linearity range.
3. Precision: The precision of the analytical method is the degree of agreement among individual test results and how individual test results are scattered from the mean value usually expressed as Standard Deviation or as the Relative Standard Deviation (Coefficient of Variation).
4. Repeatability: Precision of the method when repeated by the same analyst, same test method and under same set of laboratory conditions (reagents, equipment etc.) within a short interval of time, the only difference being the sample.
5. Reproducibility: When the procedure is carried out by different analysts, in different laboratories using different equipment, reagents by using the sample from the same homogenous batch in each case.
6. Linearity: The linearity of an analytical procedure is its ability to produce results that are directly or indirectly proportional to the concentration of the analyte in the sample within a given range, response to be linear on at least 6-7 points.
7. Range: Range is the lowest or highest level of analyte that the method can determine with reasonable accuracy and precision in the range of 80 to120 % of claim for drug products.
• For impurities studies the range is 50 to 120% and for content uniformity the range  lies from 70 to 130%.
8. Limit of Detection (LOD): The lowest amount of analyte in a sample which can be detected but not quantitated as an exact value. This is the parameter of limit test.
9. Limit of Quantitation (LOQ): The lowest amount of analyte in the sample which can be quantitatively determined with defined precision and accuracy under the state of experimental conditions
10. Robustness: Robustness is the measure of the capacity of an analytical method to remain unaffected by small but deliberate variation in procedure. It provides an indication about variability of the method during normal laboratory conditions.
11. Ruggedness: Ruggedness is the degree of reproducibility of test result obtained by analyzing the same sample under variety of normal test conditions
12. System Suitability:  System suitability is a set of parameters that are used to verify that system is satisfactory for the intended use. It is mostly applied in HPLC and GC analysis.
13. Parameters Include relative Standard deviation (RSD), Theoretical Plates, Resolution, Signal to Noise ratio, and retention time.

Presented By

Muhammad Atif

PhD Scholar Pharmaceutical Sciences AWKUM

Manager QA Decent Pharma Islamabad.