BIOANALYTICAL METHOD DEVELOPMENT AND METHOD VALIDATION IN HUMAN PLASMA BY USING LC MS/MS

Abstract

Bioanalytical method development plays importance role in the pre-clinical and clinical studies. Pharmacokinetics of any drug and its metabolite can be recognized by bioanalytical studies. The quantitative analysis of drugs and their metabolite sin the biological media is done by bioanalytical studies. Physical-chemical and biological techniques are used for these studies. Every bioanalytical method should be selective, sensitive and reliable for the quantitative estimation in drug discovery process. Bioanalytical method development consists of sample preparation, chromatographic separation and detection by using proper analytical method. Each developed method should be validated as per the regulatory authorities, so as to give reliable and reproducible method for the intended use. Many analytical techniques can be used for bioanalysis; LCMS/MS is one of them. In Liquid chromatography-mass spectrometry [LC-MS/MS] the separation of analyte is done by LC and detection is carried out by MS. LC-MS/MS obviously used in estimation and understanding of bioavailability, bioequivalence and pharmacokinetic data. This review additionally centered on different validation parameters such as: accuracy, precision, sensitivity, selectivity, standard curve, limits of quantification, range, recovery stability, etc. Keyword: Solid phase extraction, Liquid-Liquid Extraction, cartridge, LC MS/MS, Bioanalysis, Validation.