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INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH

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IJPR included in UGC-Approved List of Journals - Ref. No. is SL. No. 4812 & J. No. 63703

Published by : Advanced Scientific Research
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0975-2366
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IJPR 9[3] July - September 2017 Special Issue

July - September 9[3] 2017

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An Efficient, Simple and Convenient Process for the Synthesis of Two Imatinib Mesylate Impurities and Spectral Characterization

Author: CHAMARTHI RAJU, MANDALA CHANDRASHEKAR, AJAT SHATRU, NEERAJ KUMAR, KALLURI SESHAIAH, CHAMARTHI NAGA RAJU
Abstract: Imatinib Mesylate (1) is an endured powerful drug used for the treatment of multiple cancers. Several possibilities are conceivable for the formation of impurities in the process of synthesis of active pharmaceutical ingredients. In the processes development of Imatinib Mesylate, we have found impurities and two of them were identified as N-[4-methyl-3-(4-methyl-3-yl-pyrimidin-2-ylamino)-phenyl]-4- chloromethyl benzamide (5) (Impurity-I genotoxic impurity) and 4-[(4-methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl] amino] phenyl]-benzamide (7) (Impurity-II). In the present study, we developed a simple, efficient and convenient method for the synthesis of two impurities of Imatinib Mesylate using starting materials, 4-methyl benzoic acid (2) and 6-methyl-N-(4-(pyridin-3-yl)pyrimidin-2-yl)benzene-1,3-diamine (4) with simple workup procedure followed purification and recrystallization. The structures of the impurities were characterized by IR, NMR (1H and 13C), LC-mass and HPLC analysis.
Keyword: Imatinib Mesylate, Anti-cancer drug, Impurities, Genotoxic impurity, 4-methyl benzoic acid.
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0.12
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