RP-HPLC法测定盐酸地尔硫缓释胶囊中盐酸地尔硫的含量

Determination of diltiazem hydrochloride sustained release capsules by RP-HPLC

目的：建立反相高效液相色谱法测定盐酸地尔硫革含量的方法。方法：采用岛津LC-2010AHT，Diamondc18（150mm×4．6mm，5μm）色谱柱；流动相为缓冲液（取d-樟脑磺酸1．16g，用0．1mol／L醋酸钠溶液溶解并稀释至1000ml，用0．1mol/L氢氧化钠溶液调节pH值至6．2）-乙腈-甲醇（50：25：25），检测波长240nm。结果：20～200μg／ml范围内溶液浓度与峰面积呈良好的线性关系，平均回收率为100．1％，RSD为0．2％（n=9）。结论：该方法简单、快速、准确，重现性及专属性好。

Objective ： To establish an RP - HPLC method for determination of the contents of diltiazem hydrochloride in its sustained release capsules and its related substances. Methods： Shimazu LC-2010AHT DIAMOND CIs （150 mm ×4.6 mm, 5 μm） was applied as stationary phase and methanol - acetonitrile - a buffer of pH 6.2 （ 25 ： 25： 50） as mobile phase. The detection wavelength was at 240 nm. Results ： The calibration curve was linear between 20 - 200 μg/ml. The average recovery was 100.1% with RSD of 0.2% （n =9）. Conclusion： The method was simple, rapid, accurate and reproducible.