HPLC法测定肝喜乐片中齐墩果酸的含量及含量均匀度

Determination of Content and Content Uniformity of Oleanolic acid in GXLP by HPLC

目的:建立用HPLC法测定肝喜乐片中齐墩果酸含量及含量均匀度的方法。方法:采用Kromasil C18柱(4.6×150mm,5um),以乙腈-水-磷酸溶液(75:25:0.42)为流动相,流速为1.0ml.min-1,检测波长为210nm,进样量为10μl,柱温为室温。结果:齐墩果酸在0.592～2.96μg(r=0.9997)范围内呈良好的线性关系,平均回收率为99.06%,RSD=1.78%(n=5)。结论:该方法简便、准确,可作为肝喜乐片质量控制的方法。

Objiective： To establish a method for determination the content and uniformity of Oleanolic acid in GXLP. Method： The Kromasil C18 （4. 6 × 150mm, 5um） was used and mobile phase was acetonitrile -water- phosphoric acid （75： 25： 0. 42）, and its temperature was used at room temperature, with the flow rate of 1.0 ml · min- 1 and the wavelength of detection of 210 nm, and the injection amount of 10lxl. Results： The linear ranges of Oleanolic acid was at 0. 592 -2. 96μg （r = 0. 9997）, the average recoveries （n =5） was 99.06% with RSD 1.78%. Conclusion： The method was simple, accurate, and can be used for the quality control of GXLP.