A new method of development and validation of Methanesulfonic acid ester (Methyl, Ethyl) impurity content in dabigatran etexilate mesylate by GC MS

Abstract

We attempted to establish a method for estimating methane sulfonic acid methyl or ethyl ester in the dabigatran etexilate Mesylate in bulk and pharmaceutical dosage form. Dabigatran is an anticoagulant used in deep vein thrombosis and lung thrombosis. Methane sulfonic acid and ethyl sulfonic acid are DNA ethylating agents and genotoxic. These compounds can be estimated using the GC MS method using Helium as a carrier gas, and the compounds are estimated to be at 79 and 400 masses. The 60% methanol is used as diluent and blank. The method is validated as per the procedures of ICH, and all the validation parameters are within the acceptable limit of the impurities guidelines, as stated in the Q4 section. The different batches were analyzed using the same technique, and no impurities were found; hence, the batches were passed.