HPLC-ELSD法测定注射用灯盏花素中甘露醇的含量

Determination of mannitol in Breviscapine Injection by HPLC-ELSD

目的:建立注射用灯盏花素中甘露醇的含量测定方法。方法:采用HPLC-ELSD法,使用氨基柱,流动相为乙腈-水(83:17);ELSD漂移管温度(85±5)℃;空气流速2.4L·min-1;柱温:30℃。结果:甘露醇在进样量为1.0324～30.972μg时线性关系良好,回归方程为y=1.3121x+11.715,r=0.9995;平均回收率99.24%,RSD为0.04%。结论:该法结果准确,便于操作,可作为注射用灯盏花素中辅料甘露醇的质量控制方法之一。

Objective：To establish the method for determination of mannitol in Breviscapine Injection.Methods：HPLC-ELSD was used to determine mannitol in Breviscapine Injection.The Amino/NH2 chromatographic column was used to perform the assay,The mobile phase composition was acetonitrile-water （83：17） at 30℃.;Drift tube temperature：（85±5）℃,gas flow rate：2.4L·min-1.Results：The calibration curves was linear in the ranges of 1.0324～30.972μg.and regressive equations was y=1.3121x＋11.715,r=0.9995.Average recovery was 99.24%.Conclusion：The established method is simple and rapid,and satisfactory results were obtained,It is suitable for quality control of Breviscapine Injection.