by Roseboom IC, Thijssen B, Rosing H, Alves F, Mondal D, Teunissen MBM, Beijnen JH, Dorlo TPC. Journal of Pharmaceutical and Biomedical Analysis 2021, 207: 114402. doi: 10.1016/j.jpba.2021.114402
Summary: Miltefosine is under investigation for the treatment of cutaneous and post-kala-azar dermal leishmaniasis, where the dermis of the skin is infected with Leishmania parasites. Accurate target-site quantification of miltefosine is needed to optimize treatment regimens. The authors of this manuscript describe the development and subsequent validation of a sensitive method to quantify miltefosine in 4-mm clinical skin biopsies using HPLC-MS/MS. Miltefosine was stable under the conditions used to enzymatically homogenize the human skin tissue samples and there was no significant matrix effect from the human skin tissue matrix on the performance of the assay. This assay was able to successfully detect miltefosine in skin biopsies from patients with post-kala azar dermal leishmaniasis who were treated with this drug in Bangladesh.
