高效毛细管电泳法测定盐酸马尼地平片中盐酸马尼地平的含量

Determination of manidipine hydrochloride in manidipine hydrochloride tablets by high performance capillary electrophoresis

目的：建立以高效毛细管电泳法测定盐酸马尼地平片中盐酸马尼地平含量的方法。方法：以熔融石英毛细管柱（45 cm×75μm,有效长度37 cm）为固定相,运行缓冲液为30 mmol/L醋酸盐缓冲液（pH 4.5）,压力进样（3.4 kPa×5 s）,工作电压25 kV,柱温25℃,检测波长228 nm。结果：盐酸马尼地平浓度在0.025~0.250 g/L的范围内线性关系良好（r=0.999 4）,高、中、低浓度平均回收率分别为99.08%、98.19%和97.14%,RSD分别为0.31%、0.60%和1.51%。结论：该方法简便、快速、经济、重复性好,可用于盐酸马尼地平片中盐酸马尼地平含量的测定。

Aim： To establish a method for the determination of manidipine hydrochloride in manidipine hydrochloride tablets by high performance capillary electrophoresis. Methods： The determination was performed under the following conditions： fused-silica capillary of 45 cm × 75 μm（ 37 cm of effective length）; running buffer： 30 mmol /L acetate buffer（ pH4. 5）; sample injection method（ 3. 4 kPa × 5 s）; running voltage： 25 kV; column temperature： 25 ℃; detection wavelength：228 nm. Results： The linear range of manidipine hydrochloride was from 0. 025 to 0. 250 g /L（ r = 0. 999 4）. The average recoveries and RSD of manidipine hydrochloride at low,middle and high concentrations were 97. 14% with RSD of 1. 51%,98. 19% with RSD of 0. 60%,and 99. 08% with RSD of 0. 31%,respectively. Conclusion： The method is simple,rapid,economic and reproducible. It can be used to detect the content of manidipine hydrochloride in manidipine hydrochloride tablets.