HPLC法测定黄藤素结肠定位片中盐酸巴马汀的含量及有关物质的检查

Determination of the content of palmatine hydrochloride in Fibrauretinum Colon Targeting Tablets and related substances by HPLC

目的建立测定黄藤素结肠定位片中盐酸巴马汀含量及其有关物质检查的方法。方法采用高效液相色谱法,色谱柱为Platisil ODS C18(250mm×4.6mm,5μm);流动相为乙腈-4mL·L-1磷酸水溶液(28∶72);紫外检测波长为345nm;流速为1.0mL·min-1;柱温为40℃。结果在辅料干扰、光照、氧化、酸碱破坏下,方法分离度良好。在0.080 1～0.801μg范围内呈良好的线性关系,回归方程Y=61 049 X-47 307,r=0.999 8,平均回收率为99.9%,RSD为1.7%。结论该方法简便、灵敏、准确,适用于产品的质量控制。

Objective To establish a method to determine palmatine hydrochloride in Fibrauretinum Colon Targeting Tablets. Methods Acetonitrile-4 mL·L-1 phosphoric acid （28 ：72} was used as the mobile phase with a Platisil ODS C18 column （250 mm×4.6 mm,5 μm） at a flow rate of 1.0 mL·min-1 by HPLC. The detection wavelength was set at 345 nm. And the column temperature was 40℃. Results With interference trial,illumination, Hz Oz oxidation, acid and alkali stressing trial, the method showed the feature of good separation. The calibration curve was linear （r=0. 999 8） within the range of 0. 080 1-0. 801 μg for palmatine hydro- chloride, with an average recovery rate of 99.9% ,and RSD of 1.7%. Conclusion The method is simple, sensitive,accurate,and can be applied to the quality control of the drug.