Bio analytical methods are used for the quantitative analysis of drugs and their metabolites in the biological media like saliva, urine, plasma, serum. Development and validation of Bio analytical method is important to understand the pharmacokinetics of any drug and/or its metabolites. Bio analytical method development consists of three interrelated parts sample preparation, chromatographic separation and detection by using proper analytical method.
Validation of a Bio analytical method is the process by which it is established that the performance characteristics of the method meet the requirements for the intended Bio analytical application. The validation is further divided into 3 segments full validation, partial validation, and cross validation. This review describes mainly the various aspects for development of Bio analytical method and for the validation of Bio analytical methods.
Keywords: Biological matrix, Method stability, Matrix effect, Extraction.