REVIEW ON DEVELOPMENT AND VALIDATION OF BIOANALYTICAL METHOD BASED ON LC-MS/MS TECHNIQUE
*Tejas S. Patil, Dr. S. C. Khadse and Dr. S. S. Chalikwar
ABSTRACT
In this review article, the bioanalytical methods are broadly used to give quantiy of drugs and its metabolites in the matrices of plasma and this methods should be applied to studies in areas of human clinical and non-human evaluation. Bioanalytical method employ for that quantitative assessment of drugs along with their biological media in metabolites and plays an important role in assessment and construal of bioequivalence, pharmacokinetic, and toxic kinetic study. The foremost bioanalytical role is method development, its method validation, and sample analysis. Each step in that process required to be properly investigated to fix on the level to which surroundings, matrix, or else procedural variables that can obstruct the evaluation of analyte in the matrix from the time of set up to the time of analysis. Techniques such as high pressure liquid chromatography (HPLC) and liquid chromatography coupled with double mass spectrometry (LCMS-MS) can be used for the bioanalysis of drugs in body. The instruments has its individual advantages and disadvantages. Chromatographic methods of HPLC and having a gas chromatography that arefor the most part used for bioanlysis of small as well as large molecules, with LC/MS/MS. Linearity, accuracy, precision; selectivity, sensitivity, reproducibility, and stability are some of the commonly used parameters. In this bioanalytical method review article, we are anticipated to appenda few points on the subject to its method development and validation parameters, of assistance to quality assurance to determine the drug, concentration and its metabolite.
Keywords: Bioavailability, Bioequivalence, extraction technique, LC-MS/MS.
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