Design, Development and Validation of Bioanalytical Methods for Pharmaceutical Formulations – Review

Abstract

Any method developed for the analysis of analytes in biological fluids must yield consistent results despite the variations in conditions during the course of a project. An ideal bioanalytical method should include all of the probable effects that are going to occur during the routine analysis of study samples. 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. Method development for the interested drug/analyte in finished product or in process tests and the sample preparation of drug product and to provide practical approaches for determining selectivity, specificity, limit of detection, limit of quantitation, linearity, range accuracy, precision, recovery solution stability, ruggedness, and robustness of liquid chromatographic methods to support the Routine, in process and stability analysis. The present review aims to study the bioanalytical method development and validation for various pharmaceutical formulations.