A REVIEW ON BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION BY HYPHENATED TECHNIQUES

Abstract

Bio-analysis is related to the analysis of analytes (drugs, metabolites, biomarkers) in biological matrix and it involves several steps from sample collection to analysis and data reporting. Sample collection from clinical or preclinical studies; then sending the samples to laboratory for analysis, later the sample preparation will be carried. Stable sample preparation method could be achieved. The role of sample preparation is to remove interferences from the biological matrix and to extract the analyte of interest and to improve analytical system performance. Sample preparation is often labor intensive and time consuming. Final step of the analysis is the quantification of analyte by using analytical instruments. Among them, Liquid chromatography-tandem mass spectrometry (LC–MS/MS) is method of choice in bioanalytical laboratories. This is due to high selectivity and high sensitivity of the LC–MS/MS technique. Development and validation of analytical method play an important role in the discovery, development and manufacturing of pharmaceuticals. Every year, number of drugs entered into the market; hence it is mandatory to develop newer analytical methods for such drugs. After the development, it becomes necessary to validate the new analytical method. Method development is the process which proves that the analytical method is acceptable for use. Validation of analytical method gives information about various stages and parameters like accuracy, precision, linearity, Limit of Detection, Limit of Quantification, specificity, range and robustness. Validation should be done as per ICH regulatory guidelines.