高效液相色谱法测定烯丙雌醇片的有关物质

Determination of Related Substances of Allylestrenol Tablets by HPLC

目的建立烯丙雌醇片的有关物质检查方法。方法采用高效液相色谱(HPLC)法,色谱柱为Diamonsil C18柱(150mm×4.6mm,5μm),流动相为乙腈-水(95∶5),检测波长为210nm,流速为1.5mL/min。结果烯丙雌醇与强制破坏产生的降解产物的杂质峰分离良好,最低检出量为0.81ng。结论HPLC法准确、灵敏、专属性强,可用于烯丙雌醇的有关物质检查。

Objective To establish a method to determine the related substances of Allylestrenol Tablets. Methods HPLC was used and the chromatography condition was determined. The system was carried out using Diamonsil C18 column （150 mm×4. 6 mm, 5 μm） and the mobile phase of acetonitrile -water （95 ： 5） with the flow rate of 1.5 mL/min and the detection wavelength of 210 nm. Results The resolution between the peak of allylestrenol and other peaks was good. The limit of detection was 0. 81 ng. Conclusion The method is specific, accurate and sensitive, which can be used for the determination of allylestrenol.