GC-MS Determination of Mexiletine After Derivatization with N-Methyl-N-(Trimethylsilyl) Trifluoroacetamide in Pharmaceutical Formulatios and Comparison with HPLC Method

摘要

This paper describes two rapid, sensitive and specific methods based on GC-MS and HPLC techniques for determining mexiletine in pharmaceutical preparations. The GC-MS and HPLC calibration curves for mexiletine were linear in the concentration ranges of 0.5 - 5 and 0.75 - 10 mu g/mL, respectively. The relative standard deviation (RSD) for intra- and inter-day precision was less than or equal to 2.18 and 5.84%, respectively. The developed methods were applied to a pharmaceutical preparation (mexitil) in capsulated forms, which do not require any preliminary separation or treatment of the samples. The results obtained by two methods were statistically compared, and no significant difference was found.