HPLC法测定伤科贴膏中栀子苷的含量及其稳定性研究

Study on the Content and Stability of Geniposide in Shangke Plaster by HPLC

目的：建立伤科贴膏中栀子苷的含量测定方法,并考察其稳定性。方法：采用高效液相色谱法测定栀子苷含量：色谱柱为XTerraRP18（250 mm×4.6 mm,5μm）,流动相为乙腈-水（8∶92,V/V）,流速为1.0 ml/min,检测波长为238 nm;再采用光照试验和高温加速试验考察其稳定性。结果：栀子苷进样量在0.24-1.20μg范围内与峰面积积分值呈良好线性关系（r=0.999 9）,平均加样回收率为97.36%（RSD=1.29%,n=6）;伤科贴膏在光照（4 000 lx）下30 d内,栀子苷含量无明显变化;采用高温加速试验法预测该制剂的有效期为1.54年。结论：伤科贴膏在光照及高温条件下稳定性良好。该方法的建立可为制剂的临床应用和贮藏提供动力学数据。

OBJECTIVE： To establish the method for the content determination of geniposide in Shangke plaster, and to investigate its stability. METHODS： The content of geniposide was determined by HPLC. The determination was performed on XTer- raRP18 （250 mmx4.6 mm