Abstract

HASSANLOU, Sepideh; RAJABI, Mehdi; SHAHRASBI, Abdol ali  and  AFSHAR, Minoo. Development and validation of an ecofriendly HPLC-UV method for determination of capecitabine in human plasma: application to pharmacokinetic studies. S.Afr.j.chem. (Online) [online]. 2016, vol.69, pp.174-179. ISSN 1996-840X.  http://dx.doi.org/10.17159/0379-4350/2016/v69a21.

A simple, rapid, cost-effective and green high-performance liquid chromatographic assay for determination of capecitabine in human plasma using a C₁₈ reversed-phase analytical column was developed and validated. The separation was conducted by means of a mobile phase composed of formic acid solution (pH = 3): ethanol (55:45) running at a flow-rate of 1.0 mL min-1 with UV detection at 310 nm. The column temperature was set at 50 °C. Sample preparation involved protein precipitation by zinc sulfate-ethanol solution. This method is consistent with a high recovery of capecitabine in human plasma ranging from 95.98 to102.50 %.The calibration curves were linear over concentration range of 0.05-10.00 mL-1(r²> 0.9999). Between- and within-day variability was less than 15 % and the bias was within ±15 %. This validated method was successfully applied to a pharmacokinetic study enrolling seven Iranian cancer patients after administration of a morning oral dose of 1500 mg.

Keywords : Capecitabine; RP-HPLC method; ecofriendly; pharmacokinetics; human plasma.

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