Volumetric absorptive microsampling (VAMS) as an alternative to conventional dried blood spots in the quantification of miltefosine in dried blood samples

被引:64
|
作者
Kip, A. E. [1 ,2 ]
Kiers, K. C. [1 ]
Rosing, H. [1 ]
Schellens, J. H. M. [2 ,3 ]
Beijnen, J. H. [1 ,2 ,3 ]
Dorlo, T. P. C. [2 ,4 ]
机构
[1] Slotervaart Hosp, Antoni van Leeuwenhoek Hosp, Dept Pharm & Pharmacol, POB 90440, NL-1006 BK Amsterdam, Netherlands
[2] Univ Utrecht, Fac Sci, Utrecht Inst Pharmaceut Sci, Div Pharmacoepidemiol & Clin Pharmacol, Univ Weg 99, NL-3584 CG Utrecht, Netherlands
[3] Antoni van Leeuwenhoek Hosp, Netherlands Canc Inst, Dept Clin Pharmacol, POB 90203, NL-1006 BE Amsterdam, Netherlands
[4] Uppsala Univ, Pharmacometr Res Grp, Dept Pharmaceut Biosci, Box 570, S-75123 Uppsala, Sweden
关键词
Miltefosine; Volumetric absorptive microsampling (VAMS); Hematocrit; Dried blood; Bioanalysis; LC-MS/MS; QUANTITATIVE BIOANALYSIS; VISCERAL LEISHMANIASIS; WHOLE-BLOOD; ASSAY BIAS; LC-MS/MS; HEMATOCRIT; VALIDATION; DBS; COLLECTION; RECOVERY;
D O I
10.1016/j.jpba.2016.12.012
中图分类号
O65 [分析化学];
学科分类号
070302 ; 081704 ;
摘要
Miltefosine is an oral agent against the neglected tropical disease leishmaniasis, which is mostly endemic in resource-poor areas. Dried blood spot (DBS) sampling is an attractive alternative to plasma sampling for pharmacokinetic studies in these remote areas, but introduces additional variability in analyte quantification due to possible blood spot inhomogeneity and variability in blood spot volume and haematocrit values. Volumetric absorptive microsampling (VAMS) potentially overcomes a few of these issues as the VAMS device absorbs a fixed volume that is processed as a whole. We developed and validated an LC-MS/MS method for the quantification of miltefosine with this novel sampling technique with good performance in terms of linearity, selectivity, accuracy (bias within +/- 10.8%), precision (CV% <= 11.9%), recovery, carry-over and matrix effect. VAMS samples were stable for at least one month at room temperature and 37 degrees C. The impact of haematocrit on assay accuracy was reduced compared to conventional DBS sampling, but indicated a declining recovery with increased haematocrit due to haematocrit dependency in recovery from the sampling device. A clinical validation will be required to investigate whether VAMS is an appropriate and cost-effective alternative sampling method to conventional DBS sampling. (C) 2016 Published by Elsevier B.V.
引用
收藏
页码:160 / 166
页数:7
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