Application of SDS Micelles as Carriers for Reliable Determination of Fexofenadine and Its Impurities in Bulk and Pharmaceutical Formulations by Capillary Micellar Electrophoresis

Abstract

& A reversed-polarity capillary electrophoretic method based on application of sodium dodecyl sulfate (SDS) micelles as the carriers was developed for separation and determination of Fexofenadine (FXN) hydrochloride and its three major structural impurities in bulk and a tablet dosage form. CE analysis was performed using untreated fused-silica capillary of 50 lm internal diameter and 75-cm total length (25-cm effective length). The voltage applied of À25 kV at 25 C, and the detection wavelength was set at 225 nm. The running buffer was a 150 mM phosphate buffer at pH ¼ 3.0, containing 22 % v=v acetonitrile and 25 mmol SDS. Terfenadine was used as the internal standard (IS). The proposed method was found selective for determination of the main drug and its major impurities. The limit of quantification (LOQ) for FXN and impurities D10, D11, and A were found 70 lg=mL, 50 lg=mL, 80 lg=mL, and 100 lg=mL, respectively. The regression data obtained from the calibration plots indicated linear relationship (r 2 ¼ 0.997) over the concentration range of 70-500 lg=mL of FXN. Repeatability and reproducibility of the method, assessed as intra-day and inter-day variation and expressed as RSD ( %), were less than 4 % for relative peak area. Then, the method was applied for the determination of FXN in bulk and a tablet dosage form.

A comprehensive review of the analytical methods used for the determination of selected antihistamines in pharmaceutical dosage forms and biological fluids

“…In this way, the separation range was spread to the physiological pH region, and a CE analysis of FEX, present actually in its zwitterionic form, could be accomplished (Mikuš, Valášková, Havránek, & pharmacy, 2005). A reversed-polarity capillary electrophoretic method based on application of sodium dodecyl sulfate (SDS) micelles as the carriers was developed for the separation and determination of Fexofenadine (FEX) hydrochloride and its three major structural impurities in bulk and a tablet dosage form (Javid, Shafaati, Zarghi, & Technologies, 2014).…”