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

作　　者：柯云翠 朱义[1] 

机构地区：[1]杭州民生药业集团有限公司,杭州310011

出　　处：《中国现代应用药学》2009年第3期245-247,共3页Chinese Journal of Modern Applied Pharmacy

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。OBJECTIVE To establish an HPLC-RI method for the determination of the contents of mannitol and glucose in Compound Mannitol Injection. METHODS The HPLC-RI system consisted of strong acid cation exchange resin （ Ca^2 ＋ ） （ Sugar Pak Ⅰ300 mm × 6.5 mm） as stationary phase, water as mobile phase at the flow rate of 0.5 mg·mL^-1. The column temperature was（85±1 ） ℃. The differential refractive index detector temperature was 40 ℃. RESULTS The linear of glucose was 0.05-5mg·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= 643467X-15 373 （r=0.999 8,n=7）,the average recovery was 100.1% （RSD=0.73%,rt=9）. CONCLUSION This method is simple, accurate and better reproducibility, can meet with the requirement of the determination of the contents of mannitol and glucose.

关 键 词：甘露醇 葡萄糖 HPLC-RI 

分 类 号：R917.101[医药卫生—药物分析学] R917.4[医药卫生—药学]