Journal
JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES
Volume 865, Issue 1-2, Pages 55-62Publisher
ELSEVIER SCIENCE BV
DOI: 10.1016/j.jchromb.2008.02.005
Keywords
miltefosine; hexadecylphosphocholine; leishmaniasis; cutaneous leishmaniasis; liquid chromatography-tandem mass spectrometry; pharmacokinetics
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A sensitive and specific liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay for the quantification of miltefosine is presented. A 250 mu L human EDTA plasma aliquot was spiked with miltefosine and extracted by a solid-phase extraction method. Separation was performed on a Gemini C 18 column (150 mm x 2.0 mm I.D., 5 mu m) using an alkaline eluent. Detection was performed by positive ion electrospray ionization followed by triple-quadrupole mass spectrometry. The assay has been validated for miltefosine from 4 to 2000 ng/mL using 250 mu L human EDTA plasma samples. Results from the validation demonstrate that miltefosine can be accurately and precisely quantified in human plasma. At the lowest level, the intra-assay precision was lower than 10.7%, the inter-assay precision was 10.6% and accuracies were between 95.1 and 109%. This assay is successfully used in a clinical pharmacokinetic study with miltefosine. (c) 2008 Elsevier B.V. All rights reserved.
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