HPLC-RI测定复方甘露醇注射液中甘露醇、葡萄糖的含量

Determination of Mannitol and Glucose in the Compound Mannitol Injection by HPLC-RI

关键词:  甘露醇  葡萄糖  HPLC-RI

Key words:  mannitol  glucose  HPLC-RI

摘要:

目的建立复方甘露醇注射液中甘露醇、葡萄糖含量测定方法。方法用HPLC-RI法,以强酸性阳离子交换树脂(钙型)(Sugar Pak Ⅰ 300mm×6.5mm)为固定相,水为流动相,柱温(85±1)℃,流速0.5mL.min-1;检测器为示差折光检测器,池温40℃。结果甘露醇在0.15～15mg·mL-1内呈良好的线性关系,Y=643467X-15373(r=0.9998,n=7),平均回收率为100.1%(RSD=0.89%,n=9);葡萄糖在0.05～5mg·mL-1内呈良好的线性关系,Y=640151X-3719.6(r=1.0000,n=7),平均回收率为100.1%(RSD=0.73%,n=9)。结论该方法简便准确,重复性好,符合甘露醇、葡萄糖含量测定的要求。

Abstract:

OBJECTIVE To establish an HPLC-RI method for the determination of the contents of mannitol and glucose in Compound Mannitol Injection.METHODSThe HPLC-RI system consisted of strong acid cation exchange resin (Ca2+)( Sugar Pak Ⅰ300 mm×6.5 mm) as stationary phase, water as mobile phase at the flow rate of 0.5 mL ·min-1.The column temperature was(85±1)℃.The differential refractive index detector temperature was 40 ℃. RESULTSThe linear of glucose was 0.05-5 mg·mL-1,Y=640 151X-3 719.6(r=1.000 0,n=7),the average recovery was 100.1%( RSD=0.89%,n=9).The linear of mannitol was 0.15-15 mg·mL-1,Y= 643 467X-15 373 (r=0.999 8,n=7),the average recovery was 100.1% (RSD=0.73%,n=9).CONCLUSIONThis method is simple,accurate and better reproducibility,can meet with the requirement of the determination of the contents of mannitol and glucose.