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Abstract
Background: A novel and accurate high-throughput tandem mass spectroscopic method has been developed and validated for determination of imatinib, a protein-tyrosine kinase inhibitor against chronic myeloid leukemia. Materials & methods: Chromatographic separation was carried on XTerra® RP18 column (150 mm × 4.6 mm, 5 µm particle size) manufactured by Waters Corporation, MA, USA. The detection was performed on a triple quadruple tandem mass spectrometer by multiple reactions monitoring mode via electrospray ionization source. Results: The selective and sensitive method was linear in the concentration range of 9.57–4513.29 ng/ml and reported no matrix effect. Conclusion: The mean Cmax was found to be 10–15% lower in European subjects as compared with Indian subjects.
Lay abstract: We describe a new approach to determine the concentration of imatinib in plasma samples obtained after the administration of a reference and a test product of a 400-mg dose. The study was conducted to explore racial effects, involving healthy volunteers from India and Europe. The study was done after an approval of protocol and informed consent form Jamia Hamdard Institutional Ethics Committee (JHIEC), New Delhi, India. This study has been done for the first time on the two different races. The findings highlight that the bioavailability in Indian volunteers was comparable to that of European volunteers.
Acknowledgements
The authors acknowledge the support and facilities received from Sun Pharmaceutical Industries Ltd, Gurgaon, India and from Terapia in Romania, Europefor carrying out this work. The authors sincerely acknowledge the editors and the referees for their constructive feedback for improving the quality and raising the clarity of the paper.
Financial & competing interests disclosure
The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
No writing assistance was utilized in the production of this manuscript.
Ethical conduct of research
The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.