Analytical method development and validation of residual solvents in ethosuximide by GC – headspace technique

A precise, reliable GC approach has been created for estimating the amount of isopropyl alcohol (class-III residual solvent) content in ethosuximide by GC-headspace technique.The chromatographic separation was carried out using dimethyl acetamide as the mobile phase.A gas chromatographic system with the capillary column, DB-624 with dimensions of 30 m × 0.53 mm × 3 µm has been utilized for the separation of analytes.The flow rate was maintained at a mode of consistent flow with 2.0 ml/min.The temperature of the column was been maintained at 40°C for 11 min, elevated to 240°C with a speed of 30°C per min, and held at 240°C for 12.33 min.Nitrogen has been utilized as the carrier gas.The temperature of the injection has been kept at 180°C.The detector temperature has been maintained at 250°C.The gas split ratio was 20:1.The data sensitivity has been acquired at 20 Hz/ 0.1.The make-up gas flow has been kept constant at 30 ml/min.The fuel flow has been upheld at 40 ml/min.The oxidizer flow was found to be 400 ml/min.The run time was 30 min.By the ICH guidelines, the analytical procedure was validated for ethosuximide.The approach has been discovered to be linear, exhibiting a coefficient of correlation of 0.99 and a y-intercept value of 0.74.