Green inexpensive capillary electrophoretic method for the determination of Eszopiclone in pharmaceutical preparations

Abstract

Background: Eszopiclone (EZO) is a newly FDA-approved drug for the treatment of sleeping disorders (insomnia). It is a short-acting non-benzodiazepine sedative hypnotic. Objectives: The development and validation of an environment-friendly, rapid, simple, and inexpensive capillary electrophoresis (CE) for the routine determination of eszopiclone (EZO) in commercial dosage forms. Method: The method was performed using 75 μm × 82 cm fused-silica capillary (70 cm effective length). Detection was performed at 300 nm with a background electrolyte of 10 mM phosphate buffer pH 7.50 with 30kV applied voltage for 10 s at 25◦C temperature. Well-shaped peaks of eszopiclone were obtained (at tM = 4.41 ± 0.18 min). Validation was performed in terms of precision, accuracy, specificity and robustness in accordance with ICH guidelines. Results: Concentrations within the range 10–300 µg mL-1 were found to be linear with high correlation coefficient, r = 0.9998. Detection and quantitation limits were 1.36 and 4.66 µg mL-1, respectively. Our proposed method was successfully applied for eszopiclone analysis in its pharmaceutical dosage form. An analysis of variance test confirmed that there were no significant differences between the proposed method and the two reported reference methods.