• VINAYAK RAJU BODHANKAR
• PALLAVI S KANADALKAR
• UNNATI M PATEL
• DR S S PAWAR

Bioanalytical Method Development and Validation is a process i,e intended to enable a compound of interest to be identified and quantified in a given Biological matrix. Bioanalysis is an essential part in the development and discovery of drugs. Bioanalysis involves analysis of analytes i.e. drugs, metabolites, biomarkers in biological matrix and it include several steps from collection of sample to sample analysis, data compilation, calculation and reporting. First step is sample collection from clinical studies, then sending sample for analysis. Second step is preparation of sample and it is most important step in bioanalysis so as to obtain reliable results. Last step is sample analysis, detection, data compilation and evaluation of results. For separation and detection LC-MS/MS is the most suitable method of choice due to its high selectivity and sensitivity. Bioanalysis intended for estimstion of drugs and their metabolites in biological matrix plays an important role in evaluation of Bioavailability, Bioequivalanece, Pharmacokinetic and Toxicokinetic studies. In which different parameters like Sensitivity, Selectivity, Precision, Matrix effect, etc. are performed. This Review provides an updated overview of Bioanalytical Method Developmnet and Validation.

Biological matrix, Quality control samples, Bioanalysis, Bioanalytical Method development, Method Validation, Sample preparation, Chromatography.

"Bioanalytical Method Development and Validation at a glance: An Updated and concise Review", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.6, Issue 6, page no.251-263, June 2019, Available :http://www.jetir.org/papers/JETIR1908838.pdf

"Bioanalytical Method Development and Validation at a glance: An Updated and concise Review", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.6, Issue 6, page no. pp251-263, June 2019, Available at : http://www.jetir.org/papers/JETIR1908838.pdf