Validated Bioanalytical Method Development for the Determination of Alosetron in Human K2edta Plasma by Using LC-MS/MS

Francis, Xavier (2014) Validated Bioanalytical Method Development for the Determination of Alosetron in Human K2edta Plasma by Using LC-MS/MS. Masters thesis, C.L. Baid Metha College of Pharmacy, Chennai.

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AIM: The aim of this study is to develop and validate a specific bioanalytical method by LCMS/ MS for the estimation of Alosetron in K2EDTA human plasma using Alosetron D3 as internal standard OBJECTIVE: Methods of measuring drugs in biological media are increasingly important due to problems related to bioavailability and bioequivalence, new drug development, drug abuse, clinical pharmacokinetics, and drug research are highly dependent on accurately measured drugs in biological samples. For the estimation of the drugs present in the biological fluid, LCMS/MS method is consider to be more suitable since this is a powerful and rugged method. It is also extremely specific, linear, precise, accurate, sensitive and rapid. Currently there is a need in the pharmaceutical environment to develop Bio-analytical methods for the determination of Alosetron in human plasma. The developed method could then be applied to clinical trials to obtain accurate pharmacokinetic parameters in human plasma. Already HPLC-UV, LC-MS / MS, and GC-MS methods have been reported for Alosetron in various Biological media. Some of these methods use complicated extraction instruments, long and tedious extraction procedures, and large amounts of solvents or biological fluids for extraction while other methods have a long turnaround time during analysis The main objective of this work is to develop rapid, selective and sensitive HPLC-UV and LC-MS / MS methods that have short and simple extraction procedures, consume small amounts of solvent and biological fluid for extraction and a short turn-around time.CONCLUSION : The proposed method demonstrates good stability conditions for drug in biological matrix. This method is beneficial in the following aspects Less expensive Less matrix interference and the proposed sample preparation technique gives precise, accurate and reproducible response with a considerably short term analysis. A selective and sensitive Liquid Chromatography-Mass Spectrometry/Mass Spectrometry method to quantitate Alosetron in K2EDTA human plasma over the concentration range from 0.160 to 28.920 ng/ml was successfully validated. This method is suitable for sample analysis to support bioequivalence/bioavailability and/or pharmacokinetic studies of Alosetron.

Item Type: Thesis (Masters)
Uncontrolled Keywords: Bioanalytical Method Development; Alosetron; Human K2edta Plasma; Using LC-MS/MS
Subjects: PHARMACY > Pharmaceutical Analysis
Depositing User: Ravindran C
Date Deposited: 20 Oct 2017 05:29
Last Modified: 20 Oct 2017 05:29

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