ANALYSIS OF BIOLOGICAL SAMPLE BY LC-MS/MS: A COMPLETE REVIEW

Abstract

Biological sample analysis is an important aspect of medicinal product development for drug containing new active substances as well as generic products to get complete pharmacokinetic and toxicological profile which supporting the safety and efficacy of the drug substance or product. This study is mandatory, because it support new applications for drug approval by various respective regulatory authorities. As the sample concentration in biological matrix is very low, Hence LC-MS/MS is chosen as main instrument in this article, which support the analysis for quantitative application. This article provide complete review on the analysis of sample by proper selective biological matrix, sensitive analytical methods , recent advances in sample preparation and basic idea to select suitable technique for preparation of sample. It also provides a fundamental idea for assessing the reliability and overall performance of a bioanalytical method by validating the LC-MS/MS method based on various guidelines. Further various regulatory aspect of validation is also discussed in this paper.