醋酸环丙孕酮有关物质和含量测定方法研究

Study on determination methods of related substances and contents of cyproterone acetate

目的:优化现行醋酸环丙孕酮质量标准中有关物质和含量测定方法,以增强其质量的可控性。方法:采用高效液相色谱法,Phenomenex C 18 色谱柱(150 mm×4.6 mm,3 μm),以乙腈-水(45∶55)为流动相,检测波长为254 nm,柱温为40 ℃,进样体积为20 μl。结果:本法可用于测定醋酸环丙孕酮中的6种已知杂质和其他未知杂质;醋酸环丙孕酮含量测定线性范围为0.05~0.40 mg/ml( n=7, r =0.999 9),精密度和重复性良好。结论:优化后的方法简便,结果准确可靠,可更为有效地控制醋酸环丙孕酮的质量。

Objective: In order to enhance the controllability of cyproterone acetate quality, we optimized the current methods of the related substances and content determination in the quality standard. Method: The related substances and content determination was detected by high performance liquid chromatography(HPLC) method by using Phenomenex C18 column(150 mm×4.6 mm,3 μm), column temperature of 40 ℃, with acetonitrile-water(45∶55) as mobile phase. The detection wavelength was set at 254 nm, and the injection volume was 20 μl. Results: This method can be used to determine six known impurities and other unknown impurities in cyproterone acetate. The calibration curve of cyproterone acetate was linear in the range of 0.05~0.40 mg/ml(n=7, r=0.999 9) with good precision and repeatability. Conclusions: This optimized method is applicable, accurate and reliable for the quality control of cyproterone acetate.