【摘要】 目的建立测定马来酸伊索拉啶及其片剂的含量和有关物质的高效液相色谱法。方法采用Spherisorb C8色谱柱(250 mm×4.6mm,5μm,),以甲醇-水-冰醋酸(体积比60∶40∶0.6,pH=3.5)为流动相,流速为1.0 mL.m in-1,萘普生为内标,紫外检测波长为250nm。结果在25~250μg.mL-1范围内,色谱峰面积之比与质量浓度之比呈良好的线性关系,r=0.9997;平均回收率为100.3%(RSD=0.96%,n=9)。最低检测量为10 ng。结论该法准确、简便、灵敏,可用于马来酸伊索拉啶及其片剂的含量测定和有关物质检查。更多还原

【Abstract】 Objective To establish a HPLC method for the determination of irsogladine maleate and its related substances.Methods The Spherisorb C₈（250 mm×4.6 mm,5 μ m） column was used,the mobile phase was methanol-water-glacial acetic acid（60∶40∶0.6,pH=3.5）,the flow rate was 1.0 mL·min^-1.Irsogladine maleate was measured with the internal standard method.The detection wavelength was set at 250 nm.Results The calibration curve was linear in the range of 25～250 μg·mL^-1,r=0.9997.The average recovery was 100.3%（RSD=0.96%,n=9）.The minimum detection amount of irsogladine maleate was 10 ng.Conclusion This method is accurate,simple and sensitive,and it can be used for the assay or related substances control of irsogladine maleate.更多还原