反相高效液相色谱法测定肌苷氯化钠注射液中的有关物质含量

Determination of Relevent Substances in Inosine and Sodium Chloride Injection by RP-HPLC

目的建立肌苷氯化钠注射液有关物质的检测方法。方法反相高效液相色谱法,HypersiL C_(18)柱(4.6×250mm,10μm),流动相:甲醇-水(10:90),检测波长:248nm。结果肌苷及其有关物质得到基线分离(R>1.5),最低检测量为0.5ng,控制总杂质量不得过1.0%。结论本法简便、快速、准确,适用于肌苷及其制剂的质量控制。

OBJECTIVE To establish a method for the control of relevent substances in inosine and sodium chloride injection. METHODS A RP-HPLC method was developed. Chromatographic condition inclocded a Hypersil C18 colunm（4.6 × 250 mm, 10μm）with the mobile phase of methanol and water （10：90）. The UV detection wavelength was set up at 248 nm. RESULTS The peak of inosine and its relevent substances were separated completely. The LOD in 0.5ng. CONCLUSION The method was simple, repid, accuraate and can be used to control inosine and its preparations.