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Abstract

A REVIEW ON BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION

*Namrata Rajesh Magar and Patel Minhaj Sohail Shakil

ABSTRACT

Bioanalytical method is a process for quantitative measurement of a concentration of drug and their metabolites in biological fluid such as a biological matrix like blood, serum, plasma, urine, saliva, etc. Drug can often be quantitatively measured by different method such as liquid-liquid extraction, solid phase extraction, protein precipitation, Ligand binding assay, etc. Technique which is widely used such as High-Pressure Liquid Chromatography (HPLC) and liquid chromatography coupled with double mass spectrometry (LCMS-MS) used in bioanalysis of drugs in body. Validation is very important for effective running of pharmaceutical firms at every stage from raw material to finish at everywhere validation was performed. In this review article we discussed various bioanalytical method development and validation parameters according to US-FDA guidelines such as selectivity, accuracy, precision, recovery, calibration curve, LLOQ, freezethaw stability, short-term stability, long-term stability, stock-solution stability, QC samples. To study and evaluate bioequivalence, bioavailability, pharmacokinetics, toxicokinetic study data and validation plays an important role.

Keywords: Bioanalytical method development and validation, Validation parameter, HPLC.


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