红景天注射液中5-羟甲基糠醛HPLC含量检测方法的建立及分析

Establishment and Analysis of HPLC Method for Determination of 5-Hydroxymethylfurfural in Hongjingtian Injection

目的:建立红景天注射液中5-羟甲基糠醛高效液相色谱(HPLC)含量检测方法,进一步分析多批次红景天注射液中5-羟甲基糠醛的含量,评价其安全性。方法:采用Agilent XDB-C18(250×4.6 mm,5μm)色谱柱,0.01%磷酸水溶液为流动相,流速为1.0 mL/min;检测波长为284 nm;柱温为30℃。结果:建立了HPLC检测红景天注射液中5-羟甲基糠醛含量的方法,经方法学考察,符合要求。进一步分析表明,34批次红景天注射液中5-羟甲基糠醛含量范围为1.321~6.927μg/mL,均低于药典规定的葡萄糖注射液中的5-羟甲基糠醛限量标准。结论:多数批次的红景天注射液中均含有微量的5-羟甲基糠醛,但根据临床用量比较,远小于葡萄糖注射液中5-羟甲基糠醛的限量标准,其安全性具有足够的保障。

Objective:To establish a HPLC method for the determination of 5-hydroxymethylfurfural in Hongjingtian injection,further analyze the content of 5-hydroxymethylfurfural in multiple batches of Hongjingtian injection and evaluate its safety.Methods:The HPLC analysis was performed on Agilent XDB C18(4.6 mm×250 mm,5μm)and the mobile phase consisted of 0.01%phosphoric acid aqueous solution at a flow rate of 1.0 mL·min-1.The detective wavelength was set at 284 nm and the column emperature was maiutain at 30℃.Results:The HPLC method for content determination of 5-hydroxymethylfurfural in Hongjingtian injection was established,which was tested by method and met the requirements.Further analysis shows that the content of 5-hydroxymethylfurfural in 34 batches of Hongjingtian injection was in the range of 1.321~6.927μg/mL,which was lower than the standard of 5-hydroxymethylfurfural in glucose injection prescribed by pharmacopoeia.Conclusion:Most of the batches of Hongjingtian injection contain a small amount of 5-hydroxymethylfurfural,but according to the clinical dosage,it is much smaller than the limit of 5-hydroxymethylfurfural in glucose injection,and its safety is sufficient.