Development and validation of GC–MS method for the determination of methyl methanesulfonate and ethyl methanesulfonate in imatinib mesylate

A gas chromatography–mass spectrometry (GC–MS) method has been developed for the identification and determination of two carcinogenic and genotoxic mesylate esters viz. methyl methanesulfonate (MMS) and ethyl methanesulfonate (EMS) in imatinib mesylate (INM). The method was optimized based on the pe...

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Bibliographic Details
Published in:Journal of pharmaceutical and biomedical analysis 2008-03, Vol.46 (4), p.780-783
Main Authors: Ramakrishna, K., Raman, N.V.V.S.S., Rao, K.M.V. Narayana, Prasad, A.V.S.S., Reddy, K. Subhaschander
Format: Article
Language:English
Subjects:
Analysis
Analytical, structural and metabolic biochemistry
Benzamides
Biological and medical sciences
Development
Drug Contamination
Ethyl Methanesulfonate - analysis
Fundamental and applied biological sciences. Psychology
Gas Chromatography-Mass Spectrometry - methods
General pharmacology
Imatinib Mesylate
Medical sciences
Mesylate esters
Methyl Methanesulfonate - analysis
Pharmacology. Drug treatments
Piperazines - analysis
Pyrimidines - analysis
Validation
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Summary:A gas chromatography–mass spectrometry (GC–MS) method has been developed for the identification and determination of two carcinogenic and genotoxic mesylate esters viz. methyl methanesulfonate (MMS) and ethyl methanesulfonate (EMS) in imatinib mesylate (INM). The method was optimized based on the peak shapes and resolution of MMS and EMS. The method was validated as per International Conference of Harmonization (ICH) guidelines in terms of limits of detection (LOD), limit of quantitation (LOQ), linearity, precision, accuracy, specificity and robustness. The LOD and LOQ values were found to be 0.3 and 1.0 μg/ml, respectively. The method is linear within the range of 1–15 μg/ml for both the compounds. These mesylate esters were not found in three different batches of pure and pharmaceutical formulations of INM.
ISSN:0731-7085
1873-264X
DOI:10.1016/j.jpba.2007.11.013