Determination of Mexiletine in Pharmaceutical Preparations by Gas Chromatography with Flame Ionization Detection

A simple and rapid method for determination of mexiletine in pharmaceutical preparations was developed and validated using gas chromatography with flame ionization detection (GC-FID). GC separation was performed in about 5 min using a HP-5 capilary column (30 m x 0.320 mm, 0.25μm). Nitrogen was used as carrier gas at a flow-rate of 2 mL min. After injection of the sample at inlet temperature 250 C, the temperature of GC oven was as follows: initial temperature was 150 C, held for 1 min, increased to 180 C at 40 C min held for 1 min, and finally to 300 C at 30 C min with a final hold of 1.5 min. Calibration curve was linear between the concentration range 2.0-14 g mL. The method was found to be specific, precise and accurate. The method was applied for the quality control of commercial mexiletine capsule form to quantify the drug and to check the formulation content uniformity.