VISIBLE SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION OF IMATINIB IN BULK AND FORMULATION
Objective: A new, simple, sensitive, precise and reproducible UV visible spectrophotometric method was developed for the determination of Imatinib in pharmaceutical formulations with alizarin.
Methods: The method is based on formation of yellow-colored complex. The UV spectrum of Imatinib in methanol showed λ max at 431 nm. Beer’s law is valid in the concentration range of 10-70 μg/ml. This method was validated for linearity, accuracy, precision, ruggedness and robustness.
Results: The method has demonstrated excellent linearity over the range of 10-70 μg/ml with regression equation y =0.013x-0.017 and regression correlation coefficient r2= 0.997. Moreover, the method was found to be highly sensitive with LOD (4.3μg/ml) and LOQ (13.07μg/ml).
Conclusion: Based on results the proposed method can be successfully applied for the assay of Imatinib in various pharmaceutical dosage forms.
2. Suresha DN, Pramila T, Tamizamani T. Method development and validation of imatinib. Int J Pharm Pharm Anal 2016;1:1-11.
3. Mahesh S, Manjusha N, Sanjay D. Development and validation of an analytical method for estimation of imatinib in bulk and solid dosage form by UV spectroscopy. Der Pharm Lett 2015;7:214-20.
4. Martindale: The drug reference. Pharmaceutical Press, Lambeth High Streets London. 36th ed.; 2009. p. 773-4.
5. MS Patil, Smita JD, R Doijad, Rajendra C, MS Dhumal Priya P. Development of UV spectrophotometric method for the determination of imatinib mesylate [ITM] in bulk and formulation. Asian J Pharm Clin Res 2013;6:54-7.
6. Satyanarayana G, Ramesh E, Jitendra P, Kumar K, Hanumantharao B. Validation of new reversed-phase high-performance liquid chromatography method for the estimation of Imatinib in the bulk and pharmaceutical dosage form. Asian J Res Chem 2010;1:6-9.
7. Chaib B, Sales K, Sagars J. Role of stem cells in cancer therapy and cancer stem cells. Cancer Cell Int 2007;7:1-11.
8. Hunter T. Treatment for chronic myelogenous leukemia: the long road to imatinib. J Clin Invest 2007;117:2036-43.
9. Rochat B, Fayer A, Widmer N, Lahrichi SI, Pease B, Decosterd LA, et al. Imatinib metabolite profiling in parallel to imatinib quantification in plasma of treated patients using liquid chromatography-mass spectroscopy. J Mass Spectrum 2008;43:736-52.
10. Ivanovic D, Medenica, Janicic B, Malenovie A. Reversed-phase liquid chromatography analysis of imatinib mesylate and impurity product in gleevee capsules. J Chromatogr B: Anal Technol Biomed Life Sci 2004;800:253-8.
11. Miura M, Takahashi N, Sawada K. Quantitative determination of imatinib in human plasma with high-performance liquid chromatography and ultraviolet detection. J Chromatogr Sci 2011;49:412-5.
12. Bouchet S, Chauzit E, Ducint D, Castaing N, Canal Raffin M, Moore N, et al. Simultaneous determination of nine tyrosine kinase inhibitors by 96-well solid-phase extraction and ultra-performance LC/MS-MS. Chin Chim Acta 2011;412:1060-7.
13. Davies A, Hayes AK, Knight, Watmough SJ, Pirmohamed M, Clark RE. Simultaneous determination of nilotinib, imatinib and its main metabolite (CGP-745880 in human plasma by ultraviolet high-performance liquid chromatography. Leuk Res 2010;34:702-7.
14. Teoh M, Narayanan P, Moo KS, Radhakrishnan S, Pillappan R, Bukhari NI, et al. HPLC determination of imatinib in plasma and tissues after multiple oral dose administration to mice. Pak J Pharm Sci 2010;23:35-41.
15. Mlejnek P, Novak O, Dolezel P. A non-radioactive assay for precise determination of intracellular levels of imatinb and its main metabolite in Ber-Abl positive cells. Talanta 2011;83:1466-71.
16. Micova K, Friedecky D, Faber E, Polynkova A, Adam T. Flow injection analysis vs ultra-high-performance liquid chromatography coupled with tandem mass spectrometry for determination of imatinib n human plasma. Clin Chim Acta 2010;411:1957-62.
17. De Francia S, D`Avolio A, De Martino F, Pirro E, Baietto L, Siccardi M, et al. New HPLC-MS method for the simultaneous quantification of the antileukemia drugs Imatinib, Dasatinib, and Nilotinib in human plasma. J Chromatogr B: Anal Technol Biomed Life Sci 2009;877:1721-6.
18. Groman A, Golebiewski P. Validation f analytical procedure control of residual ethanol, 2-propanol and ethyl acetate in pharmaceutical substance imatinib. Acta Pol Pharm 2006;63:414-6.
19. Bui H, Masquelin T, Prun T, Castle T, Dage J, Kuo MS. Investigation of retention behavior of drug molecules in supercritical fluid chromatography using linear solvation energy relationships. J Chromatogr A 2008;1206:186-95.
20. Rodriguez Flores J, Berzas Nevado JJ, Contento Salcedo AM, Cabello Diaz MP. Nonaqueous capillary electrophoresis method for the analysis of gleevee and its main metabolite in human urine. J Chromatogr A 2005;1068:175-82.
21. Diculescu VC, Chiorcea Paquim AM, Tugulea L, Vivan M, Oliveira Brett AM. Interaction of imatinib with liposomes. Voltametric AFM Characterization Bioelectrochem 2009;74:278-88.
This work is licensed under a Creative Commons Attribution 4.0 International License.