THE VALIDATION CRITERIA FOR ANALYTICAL METHODS USED IN PHARMACY PRACTICE RESEARCH

Abstract

An integral part of analytical method development is validation, i.e. once the method has been devised it is necessary to evaluate it under the conditions expected for real samples before being used for a specific purpose. Although the validation stage is crucial in method development, the importance of this step is often overlooked. This paper attempts to clarify the nomencleature of method validation and describes the validation procedure for analytical methods used for the determination of drugs in biological fluids and formulations.