Chinmaya Keshari Sahoo*
Research Scholar,Dept. of Pharmaceutics,
OUCT, Osmania University,A.P, India
*e-mail: [email protected]
Analytical method validation is a regulatory requirement that refers to the evaluation and proving that the selected analytical method shall ensure reproducible and reliable results adequate for the intended purpose.The process of analytical method validation should demonstrate that the method is fit for its purpose. The validation should follow a plan that includes the scope of the method ,the method performance characterstics and acceptance limits.The validity of an analytical method can only be verified by laboratory studies. All validation experiments used to make claims or conclusions about validity of the method should be documented in a report using various parameters.
Key words: Analytical method validation,acceptance limits, parameters
The comparision of analytical method validation of parameters are given below
I. According to USP(United States of Pharmacopoeia)
The performance characteristics required can be referred to as various steps of method validation.Thease performance characterstics are accuracy , precision ,specificity, detection limit,quantitation limit, linearity, range, robustness and ruggedness.
II. According to ICH (International Conference of Harmonization)
The performance characterstics are accuracy, detection limit, quantitation limit, linearity, range, specificity, robustness ruggedness precision (repeatability,intermediate precision,reproducibility), and system suitability
III. According to FDA (Food and Drug Administration)
The performance characterstics are specificity, analysis repeatability, injection repeatability, detection, precision (repeatability, intermediate precision, reproducibility), accuracy, linearity, limit, quantitation limit, range, robustness, ruggedness, suitability, specifications and tests and sample solution stability
IV. According to European guidelines
The performance characterstics are accuracy,precision, repeatability, intermediate precision, specificity, detection limit, quantitation limit, linearity and range.
This article summarizes the validation parameters that are recquired according to the recquirements of USP, ICH, FDA and Europian guidelines. The article gives a good comparision between the parameters.