改进高效液相色谱法测定硫酸奈替米星注射液含量  

Improving the HPLC method for determining the content of netilmicin sulfate injections

作　　者：赵述强 赵卫 史孙亮 袁耀佐 侯玉荣 耿悦 居斌 张玫 Zhao Shu-qiang;Zhao Wei;Shi Sun-liang;Yuan Yao-zuo;Hou Yu-rong;Geng Yue;Ju Bin;Zhang Mei(Jiangsu Institute for Food and Drug Control,Nanjing 210019;China Medical City,Taizhou 225300)

机构地区：[1]江苏省食品药品监督检验研究院,南京210019 [2]中国医药城,泰州225300

出　　处：《中国抗生素杂志》2018年第10期1217-1221,共5页Chinese Journal of Antibiotics

基　　金：2016年国家药品评价性抽验品种

摘　　要：目的改进高效液相色谱方法测定硫酸奈替米星注射液含量。方法色谱柱为十八烷基硅烷键合硅胶柱(4.6mm×250mm, 5μm);流动相为庚烷磺酸钠缓冲液(0.6%庚烷磺酸钠溶解于0.1mol/L的磷酸二氢钾溶液中,磷酸调pH至2.5)-乙腈(77:23, V/V);检测波长205nm;流速1.0mL/min;柱温35℃;进样量20μL。结果硫酸奈替米星浓度在0.1~1.0mg/mL范围内与峰面积的线性关系良好,相关系数r为1.0000;平均回收率为98.3%,RSD为0.5%(n=9)。改进方法与微生物检定法所测结果无显著性差异。结论该方法操作简便快捷、专属性强、线性范围宽,精密度和准确度高,重复性好,该方法可等效替代抗生素微生物检定法用于硫酸奈替米星注射液的含量测定。Objective To improve HPLC method for determining the content of netilmicin sulfate injections. Methods The chromatographic separation was performed on a C18 column（4.6mm×250mm, 5μm） that was made of octadecylsilane bonded silica gels. The mobile phase was composed of 0.6% 1-heptanesulfonic acid sodium salt in 0. lmol/L KH2PO4 （adjust pH2.5 with phosphoric acid）-acetonitrile （77：23, V/V）. The detection wavelength was 205nm and the flow rate was 1.0mL/min. The column temperature was 35℃. The injection volume was 20μL. Results The results showed that the linear concentration range of netilmicin sulfate was 0.1-1.0mg/mL and the correlation coefficient was 1.0000. The average recovery was 98.3% with RSD of 0.5% （n=9）. There was no significant differences between the results of HPLC and the microbial assay of antibiotics. Conclusion The established method is simple and specific with wide linear range, accurate and reproducible and it is an equivalent instead of microbial assay for the determination of the content ofnetilmicin sulfate injection.

关 键 词：硫酸奈替米星 高效液相色谱 抗生素微生物检定 等效替代 

分 类 号：R978.1[医药卫生—药品]