高效液相色谱法测定烯丙雌醇的含量及有关物质

HPLC determination of allylestrenol and its related substances

目的:建立烯丙雌醇含量测定及有关物质检查方法。方法:采用反相高效液相色谱法。色谱柱:Alltima C_(18)柱(5μm,4.6 mm×150 mm),流动相:乙睛-水(95:5),检测波长:205 nm(含量测定),210 nm(有关物质),流速:1.0 mL·min^(-1)。结果:烯丙雌醇与各主要杂质及强制破坏产生的降解产物的杂质峰均分离良好,烯丙雌醇浓度在107.2～964.8μg·mL^(-1)范围内,与峰面积呈良好的线性关系,回归方程:A=11370C+40119,r=0.9998(n=7);精密度为0.34%(n=6);平均回收率为99.76%(RSD=0.64%,n=9),最低检出限为4.08 ng。结论:该法准确、灵敏、专属件强,可用于烯丙雌醇的含量测定利有关物质检查。

Objective：To establish a method to determine the content and related substances of Allylestrenol. Methods：HPLC was adopted,the system was carried out using Alltima C18 column（5μm,4.6mm×150mm）and the mobile phase of acetonitrile -water（95： 5）with flow rate of 1.0mL·min^-1 and the detection wavelength of content determination was at 205 nm,of related substances determination was 210 nm. Results：The resolution between the peak of Allylestrenol and other peaks was good. The linear range of the method was 107.2 - 964.8μg·mL^-1（r=0.9998, n = 7） ;lhe average recovery was 99.76% （RSD=0. 64% ,n=9）and the limit of detection was 4.08 ng. Conclusion： The method is specific,accurate,sensitive and can be used for the determination of Allylestrenol.