HPLC法测定阿魏酸钠氯化钠注射液的有关物质

Determination of related substances in sodium ferulate and sodium chloride injection by HPLC

目的建立一种高效液相色谱法测定阿魏酸钠氯化钠注射液的有关物质。方法用Hypersil ODS2色谱柱(250 mm×4.6 mm,5μm),0.02%的磷酸溶液-甲醇-四氢呋喃(60∶35∶5)作为流动相,流速为1.0 ml.min-1,检测波长310 nm。结果阿魏酸钠的最低检出限为0.2 ng,阿魏酸钠与各杂质峰分离良好。结论该方法操作简便、专属性强,可用于阿魏酸钠氯化钠注射液的质量控制。

Aim To establish an HPLC method for determination of related substances in sodium ferulate and sodium chloride injection.Methods The HPLC method was performed on Hypersil ODS2 column（250 mm×4.6 mm,5 μm）,0.02% phosphate solution-methanol-tetrahydrofuran（60∶35∶5）as mobile phase.The flow rate was 1.0 ml·min-1,and detection wavelength was set at 310 nm.Results The detection limits for sodium ferulate was 0.2 ng.Good resolution for sodium ferulate and related substances was obtained.Conclusion The method is simple and specific, and can be used for quality control of sodium ferulate and sodium chloride injection.