Method Validation for Determination of Metformin Hydrochloride in Pharmaceutical Formulations by Capillary Electrophoresis with Capacitively Coupled Contactless Conductivity Detection

Abstract

A method for the determination of metformin hydrochloride (MH) in pharmaceutical formulations by capillary electrophoresis with capacitively coupled contactless conductivity (C4D) detection was investigated. The separation was achieved under normal polarity mode at 17.5°C, 30 kV, hydrodynamic injection (50 mbar for 8 s) and using a bare fused silica capillary 72 cm × 75 µm i.d. (detection length, 10.5 cm from the outlet end of the capillary). The optimized background electrolyte consisted of 10 mM 2-morpholinoethanesulfonic acid and 10 mM histidine, pH 6.8. C4D parameters were set at fixed amplitude of 100 V and frequency of 650 kHz. Under the optimum conditions, the method shows good linearity over the range of 10-30 µg mL-1 MH (r2=0.9971). Limits of detection and quantitation based on S/N ratio of 3 and 10 were 0.049 and 0.15 µg mL-1, respectively. The proposed method was successfully applied to the assay of MH in pharmaceutical formulations and establishing the dissolution profiles for both immediate and extended release formulations of MH.