Property | Value |
Name | Master Reference for Practice and Applications of Bioanalytical Method Development and Validation. |
Description | Research article:- *Shirode Abhay R, Khanvilkar Vineeta V, Shah Jignesh M, Chitnis Aditi P, Kotadia Bhargav V, Kadam Vilasrao J. Department of Pharmaceutical Chemistry and Pharmaceutical Analysis,Bharati Vidyapeeth’s College of Pharmacy, Navi Mumbai, Sector -8, CBD, Belapur, Navi Mumbai-400 614.
Abstract: Bioanalysis plays a key role in drug discovery process. When medicinal chemists are in the lead optimization phase of new drug discovery it is needed to know if their latest NCEs pass various drug metabolism and pharmacokinetics (DMPK) screens that check for their suitability in terms of pharmacokinetics and drug metabolism (e.g., in vitro stability, p450 inhibition and absorption potential). Bioanalytical processes can significantly enhance the drug discovery and development process. Bioanalysis helps a formulation scientists and clinical research team for the study of Bioavailability (BA) and bioequivalence (BE) of a developed dosage form of a particular drug. The use of high performance liquid chromatography (HPLC) has been the state-of-the-art analytical tool for drug-discovery bioanalysis and BA-BE studies for many decades. Over the time, the HPLC systems have improved and coupled with mass spectrometry (MS) and evolved as LC-MS then it is modified as LC-MS/MS. HPTLC is also used for the analysis of biological samples. In recent years when UPLC became commercially available, this brought biggest change. While MS/MS systems have also improved over last two decades, the basic principle of using selected reaction monitoring (SRM) for the analytical detection of the analyte of interest has remained the same. Thus we have been well served by the HPLC–MS/MS paradigm as our pre-eminent tool of choice for assaying both in vitro and in vivo samples of various types. Bioanlytical method development is a very crucial step to quantitate drug from biological matrix. Method must be established and validated to demonstrate total recovery, accuracy, precision, and robustness to determine the amount of drug present in the given biological matrix. This review will explore the approaches, chromatographic methods, and extraction techniques which are used and reported by different researchers for estimation of drug from various biological samples. This will also give valuable inputs to design a protocol for validation of a developed bioanalytical method. We predict that this review will provide significant ‘value-added’ data to many analysts and will certainly shorten the timelines of referencing for method development task.
Keywords: High performance liquid chromatography, Bioanalysis, reference. |
Filename | Shirode Abhay R et. al..pdf |
Filesize | 309.77 kB |
Filetype | pdf (Mime Type: application/pdf) |
Creator | admin |
Created On: | 12/16/2011 00:00 |
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Maintained by | Editor |
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Last updated on | 01/09/2012 22:37 |
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