高效液相色谱法测定脑心舒口服液中杂质5-羟甲基糠醛含量

目的建立测定脑心舒口服液中杂质5-羟甲基糠醛(5-HMF)含量的高效液相色谱法。方法色谱柱为Phenomenex Luna C18柱(250 mm×4.6 mm,5μm),流动相为甲醇-0.1%磷酸溶液(梯度洗脱),流速为1.0 m L/min,检测波长为284 nm,柱温为30℃,进样量为20μL。结果 5-HMF质量浓度在0.204~76.65μg/m L(r=0.999 7,n=7)范围内与峰面积线性关系良好;精密度、稳定性、重复性试验结果的RSD均小于2.0%(n=6),平均加样回收率为99.18%,RSD为1.61%(n=9)。结论该方法操作简便、结果准确,精密度、稳定性、重复性、耐用性均好,可用于脑心舒口服液中杂质5-HMF含量的测定。

Content Determination of 5-Hydroxymethylfurfural in Naoxinshu Oral Liquid by HPLC

Objective To establish a high-performance liquid chromatography(HPLC)method for the content determination of 5-hydroxymethylfurfural(5-HMF)in Naoxinshu Oral Liquid.Methods The chromatographic column was Phenomenex Luna C18 column(250 mm×4.6 mm,5μm),the mobile phase was methanol-0.1%phosphoric acid solution(gradient elution),the flow rate was 1.0 m L/min,the detection wavelength was 284 nm,the column temperature was 30℃,and the injection volume was 20μL.Results The linear range of 5-HMF was 0.204-76.65μg/m L(r=0.9997,n=7),the RSDs of precision,stability and repeatability tests were less than2.0%(n=6),the average recovery of 5-HMF was 99.18%with RSD of 1.61%(n=9).Conclusion The method is simple,accurate,precise,stable,reproducible and durable,which can be used for the content determination of 5-HMF in Naoxinshu Oral Liquid.