Gas Chromatography-Head Space-Mass Spectrometry Sensor based Quality Control of Dobutamine Hydrochloride Bulk Material for a mutagenic impurity, 2-bromopropane
B.H. Rajesh Varma, B. Sreenivasa Rao
Abstract
In the process of making dobutamine hydrochloride, there is a possibility in the development of 2-bromopropane. The 2-bromopropane falls within the genotoxic group and is typically toxic and cancer suspicious agent. In order to monitor and then evaluate 2-bromopropane trace levels in dobutamine hydrochloride pharmaceutical samples, the gas chromatography technique with mass spectrometer analyser is described in this work. The separation of 2-bromopropane deployed DB-624 analysis column (30 m x 0.32 mm, 1.8 μm). The carrier gas utilized was helium flowing at a steady rate of 1.0 mL/min. At thermal setting of 220 °C, an injector operated in split mode (1:10). Selected ion monitoring pattern was choosen for the mass spectrometer analyzer to operate in. The applied technique provided adequate accuracy in addition to precision and superior linearity in the concentration span of 1.03 ppm to 15.00 ppm for 2- bromopropane. The approach was noted to be sensitive with LOD values for 2-bromopropane of 0.34 ppm. The recovery statistics of the standard addition approach provided affirmation that the stated method had efficaciously applied in terms of selectivity for enumeration of 2-bromopropane in dobutamine hydrochloride solutions with no interference.