大株红景天注射液中5-羟甲基糠醛的限量研究

Investigation on the limit of 5-HMF in Dazhu Hongjingtian Injection

目的:建立大株红景天注射液中5-羟甲基糠醛的高效液相色谱测定方法。方法:采用Inertsustain(4.6 mm×250mm,5μm)色谱柱,以甲醇-0.01%磷酸溶液作为流动相进行梯度洗脱,流速为0.8 mL·min^-1,检测波长为284 nm。结果:高效液相色谱法检测结果5-羟甲基糠醛在0.2~100.0μg·mL^-1(r=0.9999)范围内呈良好的线性关系,其平均回收率为99.7%(RSD=1.3%,n=9)。10批样品测定结果分别为5.51、5.89、6.57、7.96、8.21、5.49、6.31、8.57、6.71、5.32μg·mL^-1。结论:高效液相色谱法测定大株红景天注射液中5-羟甲基糠醛,其操作方法简单、快速,结果准确、可靠,是一种有效的5-羟甲基糠醛的限量检测方法。

Objective:To establish an high performance liquid chromatography method for determination of 5-HMF in Dazhu Hongjingtian Injection.Methods:The test was performed in Inertsustain column(4.6 mm×250 mm,5μm)under the gradient elution of methanol and 0.01%phosphoric acid solution.The flow rate was 0.8 mL·min^-1,and the detection wavelength was 284 nm.Results:The linear range of 5-HMF fell into 0.2-100.0μg·mL^-1(r=0.9999),and the average recovery was 99.7%with RSD as 1.3%(n=9).The test results of 10 batches of samples were as 5.51,5.89,6.57,7.96,8.21,5.49,6.31,8.57,6.71 and 5.32μg·mL^-1.Conclusions:The established HPLC method is simple,quick and accurate and reliable.It is an effective method to determine 5-HMF limit in Dazhu Hongjingtian Injection.