ADVANCED ANALYTICAL METHODS: LC-MS/MS WITH MULTIPLE REACTION MONITORING (MRM MODE) FOR THE QUANTIFICATION OF TWO POTENTIAL GENOTOXIC IMPURITIES IN EMTRICITABINE DRUG SUBSTANCE

Pantula Nagendra Srinivas; P Shyamala; K Rama Srinivas; Ch Nagaraju

Abstract

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, 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, 150x2.1mm, 1.7µm and X-Select CSH C18, 150x4.6 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. The method's very Low Limit of Quantification (LOQ) and Limit of Detection (LOD) were 0.3 µg/g and 0.6 µg/g, respectively.

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