RP-HPLC法测定哈西奈德涂膜剂的含量及其原料的有关物质

RP-HPLC Determination of Halcinonide Pigmemtum and Related Compound in Halcinonide

目的:改进了哈西奈德原料的有关物质和其涂膜剂的含量测定的方法,为其质量控制提供快速、有效的分析手段。方法:色谱柱为Dikma公司的ODS柱(4.6mm×250mm,5μm),含量测定流动相:甲醇-水(74∶26),有关物质流动相:甲醇-水(70∶30),检测波长为240nm,流速为10mL·min^(-1),柱温40℃。结果:哈西奈德的浓度在2.5-75μg·mL^(-1)范围内与其峰面积呈良好的线性关系,r=0.9999。平均回收率为100.0%,RSD为0.33%(n=9)。最低检测限为0.05ng。有关物质各杂质峰与主峰之间的分离良好。结论:该法专属性强,结果准确,重现性好,可用于哈西奈德涂膜剂的含量测定和原料的杂质控制。

Objective: An HPLC method was established for the determination of halcinonide pigmemtum and its related substancs in halcinonide. Methods: A Dikma discovery ODS column(4. 6 mm×250 mm,5 μm),The mobile phase consisted of assay was methanol-water (74:26), consisted of related substance was methanol-water (70: 30). The detection wavelength was 240 nm and the flow rate was 1.0 mL·min^(-1),coloum temperature: 40℃ . Results:The calibration curves were liner between 2. 5-75 μg·mL^(-1) (r=0. 9999). The average recovery was 100. 0% (n.=9),RSD was 0. 33%. The detection limit was 0. 05 ng. Conclusion:The method is simple,rapid,accurate and suitable for the determination of halcinonide pigmemtum.