硫酸沙丁胺醇注射液有关物质液相检测方法研究

Study on the liquid phase detection method of related substances in salbutamol sulfate injection

目的对硫酸沙丁胺醇注射液建立一个专属性强的有关物质检测方法。方法高效液相色谱法(High Performance Liquid Chromatography,HPLC),用辛烷基硅烷键合硅胶为填充剂(Hypersil BDS C84.6×150 mm,3μm),流动相A:3.45 g/L磷酸二氢钠二水合物溶液(用磷酸调节pH至3.0±0.02);流动相B:甲醇:乙腈=10:90,进行梯度洗脱,流速为0.6 mL/min,柱温为25℃,检测波长为220 nm,进样体积50μL。结果主成分及15个杂质专属性良好,对其中6个杂质进行方法验证,其线性关系、重复性、回收率良好。结论主成分可与15个杂质完全分离,方法专属性强,操作简便,可用于硫酸沙丁胺醇注射液有关物质的检测。

Objective To establish a highly specific method for the determination of related substances in salbutamol sulfate injection.Methods HPLC was performed on a column packed with spherical end-capped octylsilyl silica gel(Hypersil BDS C84.6×150 mm,3μm)at the flow rate of 0.6 mL/min,the detection wavelength of 220 nm and column temperature of 25℃by gradient elution using 3.45 g/L sodium dihydrogen phosphate dihydrate solution(adjust to pH 3.0 with phosphoric acid)as mobile phase A,10 volumes of methanol and 90 volumes of acetonitrile as mobile phase B.Results The chromatograph showed good specificity of the peaks of main components and 15 impurities,and the method verification of 6 of the impurities showed good linear,repeatability and recovery.Conclusion The chromatographic peaks of the main components in salbutamol can be completely separated from the 15 impurities.The established method is highly specific,easy to operate and can be used for the inspection of related substances in salbutamol sulfate injection.