VISIBLE SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION OF IMATINIB IN BULK AND FORMULATION
DOI:
https://doi.org/10.22159/ijcpr.2020v12i2.37491Keywords:
Imatinib, Spectrophotometry, Alizarin, Method Development, ValidationAbstract
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.
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References
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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.
Published
15-03-2020
How to Cite
KUMBHAR, S., V. MATOLE, Y. THORAT, A. SHEGAONKAR, and . A. HOSMANI. “VISIBLE SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION OF IMATINIB IN BULK AND FORMULATION”. International Journal of Current Pharmaceutical Research, vol. 12, no. 2, Mar. 2020, pp. 63-67, doi:10.22159/ijcpr.2020v12i2.37491.
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