HPLC法检测细辛脑注射液的有关物质

目的:建立细辛脑注射液有关物质的高效液相色谱(HPLC)检测方法。方法:采用Diamonsil-C18色谱柱(200 mm×4.6 mm,5μm);流动相A为甲醇,流动相B为十二烷基硫酸钠、磷酸二氢钾水溶液,采用梯度洗脱,10 min后流动相A在35 min内从60%升至80%,维持5 min,流速1.0 mL/min,检测波长258 nm。结果:细辛脑的最低检测限量25 ng,细辛脑与各杂质分离良好。结论:本法简便快速,灵敏度高,准确可靠。

HPLC determination of the related substances of asarone injection

Objective:To establish a HPLC method for detection of the asarone injection′s related substances.Methods:The analytical column was Diamonsil-C18(200 mm×4.6 mm,5 μm).Using gradient elution method,the mobile phase A was methanol and the mobile phase B was lauryl sodium sulfate,potassium dihydrogen phosphate water-soluble fluid(ten minutes later,the mobile phase A rose from 60% to 80% in thirty-five minutes,kept five minutes).The flow rate was 1.0 mL/min.The detection wavelength was 258 nm.Results:The detection limits for asarone were 25 ng respectively.Good resolution for asarone and related substances was obtained.Conclusion:The method is simple,rapid,sensitive and accurate.