高效液相色谱法测定盐酸异丙嗪注射液的含量

Content determination of Promethazine Hydrochloride Injection by HPLC

目的:建立高效液相法测定盐酸异丙嗪注射液含量的方法。方法:采用Agilent Eclipse XDB-C18(4.6mm×150mm,5μm)色谱柱;流动相:乙腈-0.02mol/L磷酸二氢钾溶液[磷酸调节pH=(2.3±0.1)](70∶30);检测波长:249nm;流速1.0ml/min;柱温:26℃。结果:氢氯噻嗪在0.0498～0.9960μg范围内与峰面积呈良好的线性关系(r=0.9999),平均回收率为99.75%,RSD=0.92%(n=6)。结论:本方法简便、准确、重现性好,可用于盐酸异丙嗪注射液的质量控制。

Objective：To establish a method for the content determination of Promethazine Hydrochloride Injection by HPLC.Methods：The Agilent Eclipse XDB-C18（4.6 mm×150 mm,5 μm）column was used.The mobile phases consisted of acetonitrile and 0.02 mol/L potassium dihydrogen phosphate[adjust pH=（2.3±0.1）by phosphoric acid]（70：30）,the flow rate was 1.0 ml/min and the detection wavelength was at 249 nm.The column temperature was 26℃.Results：The linear range of Triamcinolone was at 0.049 8-0.996 0 μg（r=0.999 9）,the average recovery was 99.75% with a RSD of 0.92%（n=6）.Conclusion：The method is fast,reliable,accurate and can be used in the quality control of Promethazine Hydrochloride Injection.