不同厂家注射用甲磺酸帕珠沙星中甘露醇的含量测定  

Determination of Mannitol in Pazufloxacin Mesylate Injections From Different Manufactures

作　　者：晏菊姣 汪鑫 陈蓉 王珺 YAN Jujiao;WANG Xin;CHEN Rong;WANG Jun(Wuhan Institute for Drug and Medical Device Control,Wuhan 430075,China)

机构地区：[1]武汉药品医疗器械检验所,武汉430075

出　　处：《医药导报》2019年第10期1311-1313,共3页Herald of Medicine

基　　金：2013年国家药品中央补助地方经费项目(序号77)

摘　　要：目的建立高效液相色谱-蒸发光散射检测(HPLC-ELSD)法测定注射用甲磺酸帕珠沙星中甘露醇含量。方法采用依利特NH2色谱柱(4.6 mm×200 mm,5μm),流动相:乙腈-水(90:10),流速:1 mL·min^-1,柱温:30℃。蒸发光散射检测器,漂移管温度:90℃,空气流速:2.0 L·min^-1。结果甘露醇在0.792~7.916μg内质量对数和峰面积对数呈良好的线性关系(r=0.999 5),平均回收率为101.2%,RSD=2.1%(n=9)。结论该方法简便,快速,重复性好、准确可靠,可用于注射用甲磺酸帕珠沙星中辅料甘露醇含量的测定。Objective To establish the method of determining rnannitol in pazufloxacin mesylate injections by HPLC-ELSD. Methods The chromatographic analysis was carried on the NH2 column(4.6 mm×200 mm, 5 μm)with the column temperature at 30 ℃, the mobile phase consisted of acetonitrile-water(90:10), the flow rate was 1 mL·min^-1, ELSD was used to determine mannitol.Drift tube temperature was 90 ℃, gas flow rate was 2.0 L·min^-1. Results Mannitol showed a good linear relationship within the range from 0.792 μg to 7.916 μg(r=0.999 5).The average recovery of the method was 101.2% and RSD was 2.1%(n=9). Conclusion The method is simple, sensitive, accurate, and repeatable, which was suitable for the determining of mannitol in pazufloxacin mesylate.

关 键 词：帕珠沙星 甲磺酸 甘露醇 含量测定 高效液相色谱-蒸发光散射检测法 

分 类 号：R927.2[医药卫生—药学]