普力奇降糖胶囊质量标准研究

Quality Standards for Puliqi Jiangtang Granule

目的采用高效液相色谱（HPLC）法，建立普力奇降糖胶囊中所含肉桂醛的含量测定方法。方法用ODS分析色谱柱（4．6mm×250mm，5μm）；流动相为乙腈-水-磷酸（42：58：0．2）；流速1ml／min，检测波长280nm。结果HPLC法测定桂皮醛，在浓度3．2～16μg／ml时线性良好，回归方程：A=3．797C-0．004712，r=0．9996，5次测得平均加样回收率为99．41％，RSD=0．97（n=5）。结论该法操作简便，结果准确，重现性好，可作为该制剂的质量控制方法。

Objective To develop a method for determination of Cinnamaldehyde in Piliqi Jianhtang Granule by HPLC. Methods ODS Cm8（4.6 mm x 250 mm,5 μm）was used as stationary phase,acetonitrile-water-phosphoricacid（42： 58： 0.2）was used as mobile phase at the rate of I ml/min;The detection wavelength was 280 nm. Results The calibration curve was linear in the range of 3.2 - 16 μg/ml （ r = 0. 999 6）. The average recovery of the method was 99.41% ,RSD = 0.97 （ n = 5 ）. Conclusion This method was reliable and accurate . The method can be used to control the quality of preparation.