摘要
目的建立甘露醇注射液中甘露醇的含量测定方法。方法采用HPLC法，使用氨基柱，流动相为乙腈．水（83：17）；ELSD漂移管温度70℃；氮气流速2．0L／min：柱温30℃。结果甘露醇与相邻峰得到很好分离，进样量在1．008-6．048μg时线性关系良好，回归方程为Y=1．6206X＋4．13；r=0．9992；平均加样回收率：99．24％，RSD为2．01％。结论本法结果准确，便于操作，可作为甘露醇注射液的质量控制方法之一。
Objective To establish the method of determining mannitol in mannitol injection . Methods HPLC-ELSD was used to determine mannitol in mannitol injection. The chromatographic analysis were carried on a NH2 column, The mobile phase composition was acetonitrile-water （83：17） at 30℃. Drift tube temperature： 70℃, gas flow rate： 2.0L/min. Results Mannitol and the adjacent peaks are well separated. The calibration curves was linear in the ranges of 1.008-6.048μg.and regressive equations was Y=1.6206X＋4.13. r=0.9992. Average recoveries was 99.24%. Conclusion The method is simple and rapid and with satisfactory results, It is suitable for quality control of mannitol injection.
出处
《中国中医药现代远程教育》
2010年第18期241-242,共2页
Chinese Medicine Modern Distance Education of China
