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Article Title

Determination of Ondansetron and Metabolites in Plasma and its Pharmacokinetics in Cancer Patients

Abstract

Ondansetron is a novel 5-hydroxy-tryptamine3 (5-HT3) receptor antagonist which is a drug used clinically for chemotherapy-, radiotherapy-and postoperation induced nausea and emesis. A simple, sensitive, precise and accurate HPLC method for the determination of ondansetron and its metabolites 7-hydroxy-ondansetron and 8-hydroxy-ondansetron in plasma is reported. Samples were prepared by a traditional, inexpensive solvent extraction method,The method employed a CN analytical column with an isocratic mobile phase of 20% acetonitrile in 80% 0.0125 M NH4OAc (pH=4.7)and ultraviolet detection at 305nm. Using this method, the calibration curves of ondansetron, 7-hydroxy-ondansetron and 8-hydroxy-ondansetron in plasma in the range of interest (20-800 ng/m1, 100-800 ng/ml and 100-1000ng/ml , respectively) showed good linearity (r>0.999) and precision(both between-day and within-day coefficients of variation less or around 10%).The lower detection limits of this assay method for ondansetron and its 7-OH and 8-OH metabolites were 5 ng/ml, 10ng/ml and 10 ng/ml respectively.This method has been successfully applied to the pharmacokinetic study of ondansetron in cancer patients receiving single i.v. infusion followed by a multiple oral dose of ondansetron.

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