科研之友
微信
新浪微博
Facebook
分享链接
摘要
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 mu m internal diameter and 75-cm total length (25-cm effective length). The voltage applied of -25kV at 25 degrees C, and the detection wavelength was set at 225nm. The running buffer was a 150mM phosphate buffer at pH=3.0, containing 22% v/v acetonitrile and 25mmol 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 mu g/mL, 50 mu g/mL, 80 mu g/mL, and 100 mu g/mL, respectively. The regression data obtained from the calibration plots indicated linear relationship (r(2)=0.997) over the concentration range of 70-500 mu g/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.
- 出版日期2014-1-2
