ABSTRACT

Bioanalytical method employed for the quantitative determination of drugs and their metabolites in biological fluids plays a significant role in the evaluation and interpretation of bioequivalence, pharmacokinetics and toxic kinetic studies. For various types of drug approval processes at different timings to regulate and harmonize bioanalytical method development and validation is required. Gas chromatography, high-pressure liquid chromatography, LC and GC, combined with mass spectrometric (MS) procedures such as LC-MS, LC-MS-MS, GC-MS, and GC-MS-MS are used for quantitative 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. Bioanalytical method development and validation can be performed with various validation parameters by using LC-MS/MS and other analytical techniques. Also, there are various stability guidelines and procedures were set which are useful for bioanalysis. The present review is having a special concern on regulatory and practical perspectives to researchers for development and validation of the bioanalytical method. Keywords: Bioanalytical method development, Sample extraction Techniques, Instrumentation for bioanalytical method development, Validation parameters
Publication date: 01/06/2023

https://ijbpas.com/pdf/2023/June/MS_IJBPAS_2023_6085.pdf

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https://doi.org/10.31032/IJBPAS/2023/12.6.6085