复方乙醇手消毒液中连翘质量标准研究

Quality Standard of Forsythiae Fructus in Compound Ethanol Hand Sanitizer

目的建立复方乙醇手消毒液中连翘的质量标准。方法采用薄层色谱(TLC)法对制剂中的连翘进行定性鉴别;采用高效液相色谱(HPLC)法测定制剂中连翘酯苷A和连翘苷的含量,色谱柱为中谱红RD-C_(18)柱(250mm×4.6mm,5μm),流动相为0.1%磷酸溶液-乙腈(梯度洗脱),流速为1.0mL/min,检测波长为235nm,柱温为30℃,进样量为10μL。结果连翘的TLC图斑点清晰,分离度好,且阴性对照无干扰。连翘酯苷A和连翘苷的质量浓度分别在9.79~195.75μg/mL(r=0.9999)和2.02~40.48μg/mL(r=0.9998)范围内与峰面积线性关系良好;精密度、重复性、稳定性试验结果的RSD均小于1.0%,平均加样回收率分别为100.04%和97.36%,RSD分别为0.93%和1.05%(n=6)。结论所建标准可用于复方乙醇手消毒液中连翘的质量控制。

Objective To establish the quality standard of Forsythiae Fructus in Compound Ethanol Hand Sanitizer.Methods Thin-layer chromatography(TLC)method was used for the qualitative identification of Forsythiae Fructus in the preparation.High-performance liquid chromatography(HPLC)method was used for the content determination of forsythoside A and forsythrin in the preparation,the chromatographic column was medium spectrum red RD-C_(18) column(250mm×4.6mm,5μm),the mobile phase was 0.1% phosphoric acid solution-acetonitrile(gradient elution),the flow rate was 1.0mL/min,the detection wavelength was 235nm,the column temperature was 30℃,and the injection volume was 10μL.Results The TLC spots of Forsythiae Fructus were clear with good separation,and the negative control had no interference.The linear ranges of forsythoside A and forsythrin were 9.79-195.75μg/mL(r=0.9999)and 2.02-40.48μg/mL(r=0.9998),respectively.The RSDs of the precision,repeatability and stability tests were less than 1.0%,the average recoveries of forsythoside A and forsythrin were 100.04% and 97.36% with RSDs of 0.93% and 1.05%(n=6),respectively.Conclusion The established standard can be used for the quality control of Forsythiae Fructus in the Compound Ethanol Hand Sanitizer.