Determination of imatinibe in human plasma using HPLC with diode-array detection.
Keywords:
imatinib, plasma, HPLC.
Abstract
The paper of Shohin I.E., Ramenskaya G.V., Medvedev Yu.V., Yarushok T.A. and Shamal L.L.
is devoted to development and validation of HPLC method determination of imatinib in human plasma
with diode-array detection. Sample preparation was made by proteins precipitations using acetonitrile.
HPLC analysis was performed on C18 (2) column (100 A, 5 μm, 4,6 x 250 mm). Methanol –phosphate
buffer pH 2.50 (54:46) at 1.0 mL/min was used as mobile phase. The standard curve was linear over the
range 0.40 μg/ml to 8.05 μg/ml of imatinib in plasma. Within-run precision was 3.31 % to 8.78 % and
between-run precision was 4.70 % to 8.25 % determined on spiked samples. The accuracy of the method
was – 10,07 % to 15,84 % (within-run) and 5,63 % to 11.19 (between-run). The lower limit of
quantification was 0.40 μg/ml. The method was applied to comparative pharmacokinetics study of
imatinib drug products in patients.
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промышленности на период до 2020 г». Министерство промышленности и торговли
Российской Федерации. – М., 2009 г.
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arma2020_231009.pdf (проверено 16.06.2012).
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обращении лекарственных средств».
6.FDA bioequivalence Guidance on Imatinib Mesylate. Finalized Oct. 2011.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidan
ces/ucm118261.pdf. (проверено 16.06.2012).
7.Teoh M., Narayanan P., Moo K.S., Radhakrisman S., Pillappan R., Bukhari N. and
Segarra I. HPLC determination of imatinib in plasma and tissues after multiple oral dose
administration to mice// Pak. J. Pharm., Sci. 2003. Vol. 23. No. 1. P. 35-41.
8.Schleyer E, Pursche S., Kohne C.H. Liquid chromatographic method of detection.
and quantitation of STI-571 and its main metabolite N-desmethyl-STI in plasma, urine,
cerebrospinal fluid, culture medium and cellpreparations// J Chromatogr B Analyt Technol
Biomed Life Sci. 2004. Vol. 799. P. 23-36.
9.Velpandian T., Mathur R., Agarwal N.K., Arora B., Kumar L., Gupta S.K.
Development and validation of a simple liquid chromatographic method with ultraviolet
detection for the determination of imatinib in biological samples// J Chromatogr B Analyt
Technol Biomed Life Sci. 2004. Vol. 804. P. 431-434.
10. Widmer N., Beguin A., Rochat B. Determination of imatinib (Gleevec) in human
plasma by solid-phase extraction-liquid chromatography-ultraviolet absorbance detection//
J Chromatogr B Analyt Technol Biomed Life Sci. 2004. Vol. 803. P. 285-292.
11. Oostendorp R.L., Beijnen J.H., Schellens J.H., van Tellingen O. Determination of
imatinib mesylate and its main metabolite (CGP74588) in human plasma and urine
specimens by ion-pairing reversed-phase high-performance liquid chromatography//
Biomed Chromatogr. 2007. Vol. 21. P. 747-754.
12. le Coutre P., Kreuzer K.A., Pursche S. Pharmacokinetics and cellular uptake of
imatinib and its main metabolite CGP74588// Cancer Chemother Pharmacol. 2004. Vol.
53. P. 313-323.
13. Titier K., Picard S., Ducint D. Quantification of imatinib in human plasma by highperformance
liquid chromatography-tandem mass spectrometry// Ther Drug Monit. 2005.
Vol. 27. No. 5. P. 634-640.
14. Awidi A., Salem I.I., Najib N., Mefleh R., Tarawneh B. Determination of imatinib
plasma levels in patients with chronic myeloid leukemia by high performance liquid chromatography-ultraviolet detection and liquid chromatography-tandem mass
spectrometry: Methods' comparison// Leuk Res. 2010. Vol. 34. No. 6. P. 714-717.
15. Guidance for Industry: Bioanalytical method validation. U.S. Department of
Health and Human Services, Food and Drug Administration, Center for Drug Evolution
and Research (CDER). U.S. Government Printing Office: Washington, DC, 2001.
16. Guideline on validation of bioanalytical methods (draft). European Medicines
Agency. Committee for medicinal products for human use: London, 2009.
Published
2019-11-20
How to Cite
Shohin, I. E., Ramenskaya, G. V., Medvedev, Y. V., Yarushok, T. A., & Shamal, L. L. (2019). Determination of imatinibe in human plasma using HPLC with diode-array detection. Sorbtsionnye I Khromatograficheskie Protsessy, 13(2). Retrieved from https://journals.vsu.ru/sorpchrom/article/view/1616
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