Abstract

A REVIEW ON BIOANALYTICAL SAMPLE PREPARATION METHOD AND METHOD DEVELOPMENT AND VALIDATION

Rachana Sanjay Khairnar* and Prashik Sudhir Shimpi

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Abstract

The development of sound bioanalytical method(s) is of paramount importance during the process of drug discovery and development, culminating in a marketing approval. Selective and sensitive analytical methods for the quantitative evaluation of drugs and their metabolites (analytes) are critical for the successful conduct of preclinical and/or biopharmaceutics and clinical pharmacology studies. Quantification of low molecular weight molecules using liquid chromatography–tandem mass spectrometry in biological fluids has become a common procedure in many preclinical and clinical laboratories. Bioanalytical method development largely depends on the experience and the preference of the developer. Mathematical models could help in selecting the proper conditions to develop a selective and robust method, using liquid chromatography, liquid–liquid extraction and solid phase extraction. 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. Applications of bioanalytical method in routine drug analysis also take into consideration in this article. These various essential development and validation characteristics for bioanalytical methodology have been discussed with view to improving the standard and acceptance in this area of research.

Keywords: Bioanalytical Method, Development, Validation.