高效液相色谱法测定肌苷注射液中次黄嘌呤和鸟苷的含量

Determination of the content of hypoxanthine and guanosine in inosine injection by HPLC

目的建立高效液相色谱法(HPLC)测定肌苷注射液中次黄嘌呤和鸟苷含量的方法。方法采用Shiseido Superiorex ODS色谱柱(4.6mm×250mm,5μm);以甲醇-水(10∶90)为流动相;流速1.0ml/min;检测波长248nm。结果次黄嘌呤的线性范围为0.05～5μg/ml,r=0.9999,最低检测限为8.5ng;鸟苷的线性范围为0.05～5μg/ml,r=0.9998,最低检测限为14.2ng。结论次黄嘌呤及鸟苷杂质峰与肌苷峰能达到有效分离,而且操作方法简便、准确、稳定,专属性强。该方法可用于肌苷注射液有关物质的检查。

Objective To establish a method of determining hypoxanthine and guanosine in inosine injection by HPLC.Methods Using Shiseido Superiorex ODS column（4.6mm×250mm,5μm）;considering the methanol-water（10：90） as mobile phase,the flow rate was 1.0ml/min,UV detection was 248nm.Results The linear of hypoxanthine was 0.05~5μg/ml,r=0.9999,the limit of detection was 8.5ng;The linear of guanosine was 0.05~5μg/ml,r=0.9998,the limit of detection was 14.2ng.Conclusion The peak of related substances inosine can be separated effectively.Moreover,the method of operation is so simple,accurate,stable,specific.It can be used to determine the related substances of inosine injection.