Hi friends in this blog I would like to putforth few aspects regarding the analytical method validation parameters and its procedure.

"Analytical method validation is the process of demonstrating that the analytical method is acceptable for its intended purpose."[1] Generally the user or developer of the method generates evidence on accuracy, precision, specificity, linearity range, detection limit, quantitation limit, ruggedness and robustness of the method for regulatory submission.[2]

Analytical method validation is a vital activity in the discovery of drugs and pharmaceuticals. Method validation can be considered as a process of defining the analytical requirements and confirming that the method under consideration has performance capabilities with what the application requires. In general there is often a need to transfer methodology from one laboratory to another to include it in official compendia. In such exercisers the use of a method by large number of people in various laboratories all across the world and on instruments manufactured by different manufacturers occurs causing a greater probability of decreased reproducibility and reliability. [2]Therefore in order to minimize these differences there are various standard validation parameters.

VALIDATION PERFORMANCE CHARACTERISTICS: [1]

SPECIFICITY: It is the ability to measure desired analyte in a complex mixture.

ACCURACY: It is the agreement between measured and real value.

PRECISION: It is the agreement between a series of measurements.

LINEARITY: It is the proportionality of measured value to concentration.

RANGE: It is the concentration interval where method is precise, accurate and linear.

DETECTION LIMIT: It is the lowest amount of analyte that can be detected.

QUANTITATION LIMIT: It is the lowest amount of analyte that can be measured or quantified.

ROBUSTNESS: Ability to remain unaffected by small changes in parameters.

RUGGEDNESS: Reproducability under normal but variable laboratory conditions.

DESCRIPTION OF VARIOUS ACTIVITIES TO BE PERFORMED DURING METHOD VALIDAION:[3]

Step1: Define method development plan and gather background information

Step2: Develop laboratory method and generate test procedure

Step3: Develop validation protocol

Step4: Define application, purpose and scope of method

Step5: Define performance parameters and acceptance criteria

Step6: Define validation experiments

Step7: Verify relevant performance characteristics of equipment

Step8: Qualify materials e.g. reagents

Step9: Perform pre validation experiments

Step10: Adjust method parameters and/or acceptance criteria

Step11: Perform full internal and external validation experiments

Step12: Develop standard operating procedures for executing method routinely

Step13: Define criteria for revalidation

Step14: Define type and frequency of system suitability test and/or analytical quality control checks for routine use

Step15: Document validation experiments and approval for validation report. Finally analytical method validation is an important tool for ensuring the performance of a method.

REFERENCES:

[1]:http://www.ikev.org/haber/beuvingall.pdf as on 30-09=2011 at 9:30 pm

[2]:http://www.chem.agilent.com/Library/primers/Public/5990-5140EN.pdf as on 30-09=2011 at 9:30 pm

[3]:http://pharmtech.findpharma.com/pharmtech/data/articlestandard//pharmtec... on 30-09=2011 at 9:30 pm

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