血栓通注射液指纹图谱及多成分定量的快检研究

Fingerprint and rapid multi-component determination of Xueshuantong injection

目的建立血栓通注射液指纹图谱及多成分定量快检的方法。方法采用填料粒度细、长度短的快速分析柱,用常规HPLC建立快检方法,进行方法学考察,并将测得结果与国标方法进行比较。结果指纹图谱方法的精密度、稳定性、重复性良好,测得相似度均符合标准;多成分定量的线性、检出限、定量限、精密度、稳定性、重复性和回收率良好,且定量检测结果与国标方法很接近,表明本方法准确可靠。结论建立的方法能用于血栓通注射液指纹图谱和多成分定量的快速测定、在实际工作中容易推广,不仅能提高检验效率,还可以减少有机溶剂用量。

Objective To establish a method of fingerprint and rapid multi-component determination for Xueshuantong injection. Methods Conventional HPLC was performed on a fast short analytical column with fine granularity,and the methodology was evaluated. The measured results were compared with the national standard method. Results The fingerprint showed good precision,stability and repeatability. The similarity was in line with the standards. The linearity,limit of detection,limit of quantification,precision,stability,repeatability and recovery test of the multi-component determination showed good results,and the quantitative results were very close to the national standard method. This method was accurate and reliable. Conclusion The method could be used for Xueshuantong injection＇ s fingerprint and rapid determination,which was easily applied in practical work. It could not only improve the inspection efficiency,but also reduce the use of organic solvents.