Clinical development of imatinib: an anticancer drug. (March 2016)

• Record Type: Journal Article
• Authors: Goswami, Dipanjan; Gurule, Sanjay; Lahiry, Abhiroop; Anand, Amit; Khuroo, Arshad; Monif, Tausif
• Is Part Of: Future science OA. Volume 2:Number 1(2016)
• Publication Date: 2016-03
• Subjects: bioavailability study -- imatinib mesylate -- method development -- multiple reaction monitoring ISR -- validation; Medicine -- Periodicals; Biotechnology -- Periodicals; 610
• DOI: 10.4155/fso.15.92
• Languages: English
• ISSNs: 2056-5623

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.