Monday, July 4, 2011

Where to start Method Validation

The Analytical methods methods must be validated before they are going to use. Method validation is a laborious process include number of parameters such as specificity, Linearity, precision etc... As this process involves number of parameters a question may arise where to start the validation?


Before answering this question i would like to mention specificity should be done separately along with Forced degradation studies.


Now i am suggesting a sequence for method validation parameters to be followed during analytical method validation.


For Assay method
System suitability ----> System precision ----> Sample precision ----> Solution stability and mobile phase stability----> accuracy ----> Linearity ----> Ruggedness ----> robustness


For Related substances and Residual solvents method
System suitability ----> System precision  ----> Sample precision ----> Solution stability and mobile phase stability ----> RRF and RRT Establishment ---->LOD ---->LOQ----> Precision at LOQ ---->Accuracy at LOQ ----> Accuracy ----> Linearity ----> Ruggedness ----> Robustness

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