Abstract
To facilitate future pharmacokinetic studies of combination treatments against leishmaniasis in remote regions in which the disease is endemic, a simple cheap sampling method is required for miltefosine quantification. The aims of this study were to validate a liquid chromatography-tandem mass spectrometry method to quantify miltefosine in dried blood spot (DBS) samples and to validate its use with Ethiopian patients with visceral leishmaniasis (VL). Since hematocrit (Ht) levels are typically severely decreased in VL patients, returning to normal during treatment, the method was evaluated over a range of clinically relevant Ht values. Miltefosine was extracted from DBS samples using a simple method of pretreatment with methanol, resulting in >97% recovery. The method was validated over a calibration range of 10 to 2,000 ng/ml, and accuracy and precision were within ±11.2% and ≤7.0% (≤19.1% at the lower limit of quantification), respectively. The method was accurate and precise for blood spot volumes between 10 and 30 μl and for Ht levels of 20 to 35%, although a linear effect of Ht levels on miltefosine quantification was observed in the bioanalytical validation. DBS samples were stable for at least 162 days at 37°C. Clinical v...Continue Reading
References
Jan 1, 1992·Progress in Experimental Tumor Research·J KöttingH Eibl
Mar 15, 2001·Journal of Pharmaceutical and Biomedical Analysis·Y Vander HeydenD L Massart
Nov 25, 2003·Seminars in Thrombosis and Hemostasis·Oguz K Baskurt, Herbert J Meiselman
Apr 20, 2007·Transactions of the Royal Society of Tropical Medicine and Hygiene·Claudia M C GomesCarlos E P Corbett
Mar 8, 2008·Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences·Thomas P C DorloJos H Beijnen
Jun 4, 2008·Antimicrobial Agents and Chemotherapy·Thomas P C DorloPeter J de Vries
Jan 22, 2009·Analytical Chemistry·Neil SpoonerMatt Barfield
Apr 8, 2009·Therapeutic Drug Monitoring·Peter M EdelbroekLeo M L Stolk
May 27, 2010·Archives of Disease in Childhood·Parul PatelHitesh Pandya
Jul 21, 2010·British Journal of Clinical Pharmacology·Baba S MohammedJames S McLay
Nov 19, 2010·Bioanalysis·Philip Denniff, Neil Spooner
Nov 19, 2010·Bioanalysis·Gary Emmons, Malcom Rowland
Dec 28, 2010·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Henning BlumeChristoph Siethoff
Jan 5, 2011·Trials·Jesia G BerryUNKNOWN Vaccine Assessment Using Linked Data (VALiD) Working Group
Apr 2, 2011·Bioanalysis·Hitesh C PandyaHussain Mulla
Apr 5, 2011·The American Journal of Tropical Medicine and Hygiene·Michael O HarhayManica Balasegaram
Sep 1, 2011·Bioanalysis·Philip TimmermanJohn Smeraglia
Oct 21, 2011·Bioanalysis·M O'MaraN Spooner
Jul 9, 2013·Bioanalysis·Philip TimmermanUNKNOWN European Bioanalysis Forum
Aug 14, 2013·Bioanalysis·Pieter Mm De KeselChristophe P Stove
Jan 21, 2014·The Journal of Infectious Diseases·Thomas P C DorloAlwin D R Huitema
Mar 29, 2014·Memórias do Instituto Oswaldo Cruz·Maria Vitória Assumpção MourãoAna Rabello
Sep 11, 2014·Clinical Pharmacokinetics·Abraham J WilhelmEleonora L Swart
Nov 12, 2014·Bioanalysis·Nynke G L JagerJos H Beijnen
Oct 3, 2015·PLoS Neglected Tropical Diseases·Ermias DiroJohan van Griensven
Jan 1, 2015·International Journal of Neonatal Screening·Elizabeth M HallVíctor R De Jesús
Citations
Jul 9, 2016·Journal of Pharmaceutical and Biomedical Analysis·Yeliz EnderleJürgen Burhenne
Aug 1, 2016·Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences·Guru R ValicherlaJiaur R Gayen
Feb 17, 2018·Bioanalysis·Enaksha R WickremsinheDarlene K Satonin
Dec 10, 2017·Scientific Reports·A V Ibarra-MenesesE Carrillo
Oct 3, 2018·Antimicrobial Agents and Chemotherapy·Danilo César Galindo BedorIsabela Ribeiro
Aug 2, 2017·Clinical Pharmacokinetics·Anke E KipThomas P C Dorlo
Dec 8, 2020·Journal of Chromatography. a·Hui Yin Tey, Hong Heng See
Mar 8, 2021·The Journal of Antimicrobial Chemotherapy·Anke E KipThomas P C Dorlo
Oct 26, 2021·International Journal of Antimicrobial Agents·Semra PalićThomas P C Dorlo