反相高效液相色谱法测定己酮可可碱氯化钠注射液中的有关物质

Determination of related substances in pentoxifyiline and Sodium chloride injection by RP-HPLC

用RP-HPIC建立了己酮可可碱氯化钠注射液中有关物质的检测和控制方法。以Spherisorb C_(18)柱和甲醇-0.1％冰醋酸(50:50,1mL/min),得到己酮可可碱及其有关物质基线分离,用UV检测器(波长264nm)的最低检测量为4ng,控制总杂质量不得过1.0％。该法简便、快速、准确,适用于己酮可可碱及其制剂的质量控制。

To establish a method for the control of related substances in pentoxifylline and sodium chloride injection, a RP-HPLC method was developed. Chromatographic condition included a Spherisorb C18 colunm with the mobile phase of methanol and 0.1% glacial acetic acid (50:50). The UV detection wavelength was set up at 264 nm. The peak of pentoxifylline and its related substances were separated completely. The LOD was 4 ng. The method is simple, rapid and accurate. It can be used to control pentoxifylline and its preparations.