尼尔雌醇片和己烯雌酚片溶出度测定方法的改进

Dissolution Determination of Nilethylenol Tablets and Diethylstilbestrol Tablets by Improved HPLC

目的:改进尼尔雌醇片和己烯雌酚片溶出度的检验检测方法。方法:采用桨法,以含1%SDS pH 6.8磷酸盐缓冲液500 ml为溶出介质,转速为50 r·min^-1,应用高效液相色谱法,色谱柱为Agilent Eclipse XDB-C18(250 mm×4.6 mm,5μm),以0.02 mol·L^-1乙酸铵-乙腈(40∶60,v/v)为流动相,检测波长280 nm,测定尼尔雌醇片和己烯雌酚片的溶出量。结果:经45min时,尼尔雌醇片样品和己烯雌酚片样品的溶出度均超过标示量的70%。结论:改进方法较原方法灵敏度更高、准确度更好,可为提高尼尔雌醇片和己烯雌酚片的质量标准,建立合理的溶出度测定方法提供技术支持。

Objective:To improve the dissolution determination method for nilethylenol tablets and diethylstilbestrol tablets.Methods:The established dissolution determination conditions were as follows:a paddle method with 500 ml pH6.8 phosphate buffer containing 1%SDS as the dissolution medium was used,the rotation speed was 50 r·min^-1,and HPLC was used for the content detection.An Agilent Eclipse XDB-C18 column(250 mm×4.6 mm,5μm)was used,the mobile phase consisted of 0.02 mol·L^-1 ammonium acetate-acetonitrile(40∶60,v/v),and the detection wavelength was 280 nm.Results:The results showed that the dissolution rates of nilethylenol tablets and diethylstilbestrol tablets were both higher than 70%of the labeled contents in 45 min.Conclusion:The improved method has higher sensitivity and better accuracy than the original method,which can provide technical support for improving the quality standard of nillestriol tablets and diethylstilbestrol tablets and establishing a reasonable determination method of dissolution.