Validated LC-MS/MS method for the quantitative determination of the glucosylceramide synthase inhibitor miglustat in mouse plasma and human plasma and its application to a pharmacokinetic study

Journal of Pharmaceutical and Biomedical Analysis

Volumn 59, Issue 1, 2012, Pages 123-129

  Spieker, Elke ^a   Wagner Redeker, Winfried ^a   Dingemanse, Jasper ^b  

^a Swiss BioAnalytics AG   (Switzerland)

^b ACTELION PHARMACEUTICALS LTD   (Switzerland)

Author keywords

Accurate mass; Assay validation; Miglustat; N (n nonyl)deoxynojirimycin; Pharmacokinetics

Indexed keywords

1 DEOXYNOJIRIMYCIN DERIVATIVE; AMMONIUM HYDROXIDE; METHANOL; MIGLUSTAT; PLASMA PROTEIN; WATER;

ARTICLE; CONTROLLED STUDY; CYSTIC FIBROSIS; DRUG DETERMINATION; FLOW RATE; HUMAN; LIQUID CHROMATOGRAPHY; MOUSE; NONHUMAN; PLASMA; PRECIPITATION; PRIORITY JOURNAL; QUADRUPOLE MASS SPECTROMETRY; STANDARD; TANDEM MASS SPECTROMETRY;

1-DEOXYNOJIRIMYCIN; ANIMALS; CALIBRATION; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DRUG STABILITY; ENZYME INHIBITORS; GLUCOSYLTRANSFERASES; HUMANS; LIMIT OF DETECTION; MICE; REFERENCE STANDARDS; REPRODUCIBILITY OF RESULTS; SPECIES SPECIFICITY; TANDEM MASS SPECTROMETRY;

EID: 82255193062     PISSN: 07317085     EISSN: 1873264X     Source Type: Journal    
DOI: 10.1016/j.jpba.2011.10.016     Document Type: Article

References (9)

1. Horne G., Wilson F.X., Tinsley J., Williams D.H., Storer R. Iminosugars past, present and future: medicines for tomorrow. Drug Discov. Today 2011, 16:107-118.
2. (accessed 22.06.11). http://www.ema.europa.eu/ema/index.jsp%3Fcurl=pages/medicines/human/medicines/000435/human_med_001171.jsp%26murl=menus/medicines/medicines.jsp%26mid=WC0b01ac058001d124%26jsenabled=true.
3. van Giersbergen P.L.M., Dingemanse J. Influence of food intake on the pharmacokinetics of miglustat, an inhibitor of glucosylceramide synthase. J. Clin. Pharmacol. 2007, 47:1277-1282.
4. Treiber A., Morand O., Clozel M. The pharmacokinetics and tissue distribution of the glucosylceramide synthase inhibitor miglustat in rat. Xenobiotica 2007, 37:298-314.
5. Maegawa G.H.B., van Giersbergen P.L.M., Yang S., Banwell B., Morgan C.P., Dingemanse J., Tifft C.J., Clarke J.T.R. Pharmacokinetics, safety and tolerability of miglustat in the treatment of pediatric patients with GM2 gangliosidosis. Mol. Genet. Metab. 2009, 97:284-291.
6. Guitton J., Coste S., Guffon-Fouilhoux N., Cohen S., Manchon M., Guillaumont M. Rapid quantification of miglustat in human plasma and cerebrospinal fluid by liquid chromatography coupled with tandem mass spectrometry. J. Chromatogr. B 2009, 877:149-154.
7. Staak R.F., Hopfgartner G. New analytical strategies in studying drug metabolism. Anal. Bioanal. Chem. 2007, 22:1365-1380.
8. Viswanathan C.T., Bansal S., Booth B., DeStefano A.J., Rose M.J., Sailstad J., Shah V.P., Skelly J.P., Swann P.G., Weiner R. Workshop/conference report - quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays. AAPS J. 2007, 9:E30-E42.
9. rd European Cystic Fibrosis Society Conference 2010.