ABSTRACT

Development and validation of bioanalytical method is important to understand the pharmacokinetics of any drug and/or its metabolites. Liquid chromatography-mass spectrometry (LC-MS/MS) is a technique that uses liquid chromatography (or HPLC) with the mass spectrometry. (LC-MS/MS) is commonly used in laboratories for the qualitative and quantitative analysis of drug substances, drug products and biological samples. This article reviews various extraction techniques like liquid–liquid extraction, solid phase extraction and protein precipitation  which play important role in sample preparation and detection by LC-MS/MS. Bioanalytical method validation includes all of the procedures that demonstrate that a particular method used for quantitative measurement of analytes in a given biological matrix, such as blood, plasma, serum, or urine  is reliable and reproducible for the intended use.

Key words: LC-MS/MS bioanalysis, Method development, Method validation.