Research Paper | Chemistry | India | Volume 6 Issue 3, March 2017
A Selective and Sensitive Method Development and Validation by LC?MS/MS Approach for Trace Level Quantification of Potential Genotoxic Impurity IMT-01 in Imatinib Mesylate Drug Substance
Nelaturi Subbaiah, G. V. Subba Reddy
Abstract: A novel reversed-phase selective and sensitive liquid chromatography coupled with tandem mass spectrometric (LC-MS/MS) method was developed and validated for the trace analysis of (> 0.5 ng/mL level) of N- (2-methtyl-5-nitrophenyl) -4- (pyridine-3-yl) -pyrimidine-2-amine (IMT-01) genotoxic impurity in imatinib mesylate drug substance. The method utilizes Inertsil C18 column (150 mm4.6 mm, 5.0 m) with electrospray ionization in multiple reaction monitoring (MRM) detection mode. Isocratic program was developed for rapid analysis and mobile phase was 0.1 % formic acid in water and acetonitrile in the ratio of 3070 (v/v). The flow rate was 1.0 mL/min and elution was monitored by mass spectrophotometer. The method was validated as per International Conference on Harmonization (ICH) guidelines and was able to quantitate up to 0.5 ng/mL of IMT-01.
Keywords: Imatinib mesylate, LC-MS/MS, Genotoxic impurity, Isocratic program, multiple reaction monitoring MRM
Edition: Volume 6 Issue 3, March 2017,
Pages: 162 - 166
How to Cite this Article?
Nelaturi Subbaiah, G. V. Subba Reddy, "A Selective and Sensitive Method Development and Validation by LC?MS/MS Approach for Trace Level Quantification of Potential Genotoxic Impurity IMT-01 in Imatinib Mesylate Drug Substance", International Journal of Science and Research (IJSR), https://www.ijsr.net/get_abstract.php?paper_id=ART20171330, Volume 6 Issue 3, March 2017, 162 - 166
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