GC Quantification of Residual hexylmethane sulfonate in Dabigatran etexilate mesylate

Abstract

A simple and a quantitative Gas chromatography (GC) method with oncolumn injection technique have been developed for the quantification of trace level hexyl methane sulfonate in Dabigatran etexilate mesylate. The chromatographic separation is achieved on DB-Wax, (30 m x 0.53 mm x 1.0 µm) capillary column and the instrument employed for the method development and validation was Agilent6890N GC equipped with flame ionization detector (FID). GC run time was 25 min employing programmed temperature with splitless mode oncolumn injection. In the developed method the limit of detection (LOD) of Hexyl methane sulfonate is 0.25 ppm and the limit of quantification (LOQ) of Hexyl methane sulfonate is 0.75 ppm. The method is validated for specificity, linearity, accuracy and precision. The developed method can be very well employed and can be used in the quality control laboratories to monitor and control the trace level of hexyl methane sulfonate in Active pharmaceutical ingredients (API)