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Abstract
Mexiletine hydrochloride is an orally active class I antiarrythmic agent. The purpose of this work is to develop a sensitive, selective, and stability indicating reverse phase HPLC assay for the quality control analysis and stability testing of mexiletine hydrochloride dosage forms. The method was developed to quantify the drug for various formulations. Analysis was carried out on a 4 mm × 150 mm C‐18 microsorb column, using a 50:50 methanol:0.053 M sodium acetate buffer. The pH of the mobile phase was adjusted to 4.8. The flow rate was set at 1 mL/min and the analysis was carried out at 254 nm. The internal standard used in the analysis was thiamine hydrochloride. The drug eluted at about 8 min, while the internal standard eluted at about 3 min. The stability of the assay was studied by subjecting the drug to extreme pH conditions. The limit of quantification (LOQ) and limit of detection (LOD) were found to be 0.06 µg and 0.02 µg, respectively. The reproducibility of the method was tested by carrying out multiple injections on the same day, as well as, on five consecutive days. The coefficient of variation for the intra‐day and inter‐day studies was found to be 0.81% and 1.47%, respectively.