盐酸特比萘芬凝胶有关物质检查方法的建立

Study on Determination Method for Related Substances of Terbinafine Hydrochloride Gel

目的:建立盐酸特比萘芬凝胶的有关物质检查方法。方法:采用Inertsil ODS-2色谱柱(3.0×150mm,5.0μm),以0.2%三乙胺缓冲液(用稀醋酸调节pH值至7.5)-甲醇-乙腈混合溶液为流动相,按梯度进行洗脱。检测波长为280nm,流速为1.0mL/min,柱温为40℃。结果:盐酸特比萘芬凝胶经强制降解,各已知杂质峰与主成分峰,主成分峰与降解杂质峰分离度良好。使用盐酸特比萘芬与杂质B、D、E进行方法验证,其定量限、精密度以及准确度均符合要求。结论:新建的方法能对盐酸特比萘芬凝胶已知杂质B、D、E及其他杂质进行有效的控制。

Objective:To establish a method for determining related substances of Terbinafine Hydrochloride Gel.Methods:A Inertsil ODS-2(3.0×150mm,5.0μm)was used with a mobile phase consisting of 0.2%Triethylamine buffer(Adjust the pH to 7.5 with diluted acetic acid)-methanol-Acetonitrile,gradient elution.The detection wavelength was 280 nm and the flow rate was 1.0mL·min-1,Column temperature was 40℃.Results:The main peak of Terbinafine Hydrochloride Gel was well separated from specified impurities B,D,E and the degradation impurities.Using terbinafine hydrochloride and the specified impurities B,D,E to verify the method,The LOD,precision and accuracy conform to the requirements.Conclusion:The newly established method can be use for quality control of Terbinafine Hydrochloride Gel.