酞丁安搽剂有关物质测定方法研究

目的:建立一种高效液相色谱法测定酞丁安搽剂的有关物质。方法:用十八烷基硅烷键和硅胶为填充剂;乙腈-0.75%甲酸溶液(30∶70)为流动相;流速1.2ml/min,进样量20ul,检测波长280nm。结果:由专属性试验可知,产生的杂峰能与主峰分离。酞丁安主峰与其它成分分离良好,专属性良好。溶液在8小时内稳定,主峰面积变化RSD值为0.49%。检测限约为4ng。结论:该方法简便、准确,系统适用性好,可以作为酞丁安搽剂有关物质的检测方法。

Objective：To establish a high performance liquid chromatography determination phthiobuzonum liniment related material. Methods： using octadecyl silane key and silica gel as the filling agent; Acetonitrile - 0.75% formic acid solution （30, 70） as mobile phase; Velocity 1.2 ml/min, sample quantity 20 ul, detection wavelength of 280 nm. Results： the specificity test, it is known that the peak from the mixed with major peak separation. Phthiobuzone main peak and other components of the separatioh is good, good specificity. Solution in 8 hours stability, main peak area change RSD value is 0.49%. Detection limit, about 4 ng. Conclusion： this method is simple and accurate, and the system applicability is good,can be Used as＇a phthiobuzonum liniment relevant material test methods.