LC-coupled ESI MS for quantification of miltefosine in human and hamster plasma.

Background: Leishmaniasis, a fatal parasitic disease, is the second largest parasitic killer in the world and miltefosine is the first and only oral drug available for its treatment.

Results: A rapid, sensitive and simple LC-MS/MS method for miltefosine quantification in hamster and human plasma was developed and validated over the range of 2.5-400 ng/ml. The mass spectrometric detection of the drug was carried out in multiple reaction monitoring mode (m/z 408.1→125.1) using an electrospray positive ionization. The protein precipitation method was employed for sample (50 µl) cleanup.

Conclusion: The proposed method provided accurate and precise high-throughput quantification of miltefosine in plasma and was successfully applied to its oral PK study in Golden Syrian hamsters.