BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION BY RP HPLC: A COMPREHENSIVE REVIEW

The bioanalytical techniques plays an essential role in quantitation of drugs and metabolite concentration in biological fluids such blood, plasma, serum during drug discovery and development.Appropriate sample preparation, as well as method development and validation, are essential to provide accurate results.The bioanalyses are important in pharmacokinetic studies, and also contribute to the study of animal bioavailability and bioequivalence.These studies can be used to make critical decisions about the safety and efficacy of a drug.High performance liquid chromatography (HPLC) is a critical method for the detection and quantitation of drugs and metabolites in biological matrices at low concentrations.Accordingly establishing HPLC based bioanalytical methods are handy for low dose drugs.It covers novel methods of sample preparation, including liquid-liquid extraction solid-phase extraction and the protein precipitation as well as the validation parameter such as accuracy, precision, sensitivity, selectivity linearity limits of quantitation and range recovery in addition to stability in chromatographic bioanalysis.