HPLC法测定炔雌醇透皮贴剂中药物含量和有关物质

HPLC determination of the content of ethinyl estradiol and related substances in patch

目的:建立 HPLC 测定炔雌醇透皮贴剂中药物含量和有关物质的方法。方法:色谱柱为 Symmetry Shield RP 18(3.9 mm×150 mm,5 μm),乙睛-水(45:55)为流动相,流速为1.0 mL·min^(-1),检测波长为220 nm。结果:此方法的线性范围为4.27～68.29μg·mL^(-1)(r=0.9999),平均回收率(n=9)为99.7%。炔雌醇及其有关物质峰之间能完全分离。结论:该方法灵敏准确,可作为炔雌醇透皮贴剂中药物含量和有关物质的测定方法。

Objective： To establish an HPLC method for determination of the content of ethinyl estradiol and related substances in patch. Method： HPLC with Symmetry Shield RP 18 （3.9 mm × 150 mm ,5 μm） , acetonitrile and water（45 ： 55 ） as mobile phase, flow rate ： 1.0 mL · min ^- 1 , UV detector at 220 nm. Results ： The linear range of ethinyl estradiol was 4.27 - 68.29 μg · mL^-1 （ r = 0. 9999 ）. The average recovery（ n = 9 ） was 99.7%. Ethinyl estradiol and related substances could be separated by this method. Conclusion： The method is sensitive and accurate, it can be used as a method for the determination of content of ethinyl estradiol and related substances in patch.