Der Pharma Chemica
Journal for Medicinal Chemistry, Pharmaceutical Chemistry, Pharmaceutical Sciences and Computational Chemistry
ISSN: 0975-413X
P Shyamala
Department of Chemistry, Andhra University, Visakhapatnam, IndiaPublications
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Research Article
Advanced Analytical Methods: LC-MS/MS with Multiple Reaction Monitoring (MRM Mode) For the Quantification of Two Potential Genotoxic Impurities in Emtricitabine Drug Substance
Author(s): Pantula Nagendra Srinivas*, P Shyamala, K Rama Srinivas and Ch Nagaraju
To detect Possible Genotoxic Impurities (PGIs) in Emtricitabine drug substance 2-Methoxy 4-Amino-5-Fluro pyramidine and L-Methyl glyoxalate monohydrate, two sensitive LC-MS/MS techniques were developed and verified. 2-Methoxy 4-Amino-5-Fluro pyramidine and L menthyl glyoxalate contaminants in the Active Pharmaceutical Ingredient (API) of Emtricitabine. Multiple Reaction Monitoring (MRM) mode was employed with the LC-MS/MS method on acquity UPLC CSH phenyl hexyl, 150 x 2.1mm, 1.7µm and X-Select CSH C18, 150 x 4.6 mm, 3.5 µm respectively, using Electrospray Ionization (ESI). The suggested approach was exact, robust, accurate, linear, and specific. Over the concentration range of 0.6 µg/g to 9.5 µg/g and 0.6 µg/ml to 9.4 µg/ml, the calibration curves demonstrated satisfactory linearity; the correlation coefficients were.0.999 and.0.999 in each case. Th.. Read More»
DOI: 10.4172/0975-413X.17.2.638-643