高效液相色谱法测定硫酸奈替米星注射液中奈替米星的含量

Determination of content of Netilmicin Sulfate Injection of Netilmicin by HPLC

目的建立高效液相色谱法测定硫酸奈替米星注射液中奈替米星的含量。方法色谱柱为HyPersil BDS C18(4.6×250mm,5μm);流动相为含0.05mol·L-1三氟醋酸-甲醇(80∶20);流速为1.0mL·min-1;检测波长为205nm;柱温30℃。结果奈替米星与其他有关物质分离度良好,进样量在10.15μg^50.75μg的范围内与峰面积线性关系良好(r=0.9996);平均回收率为99.61%,RSD为1.00%(n=9),辅料对检测无影响。与效价法比较,两者方法无显著性差异。结论该法快捷简便,结果准确,重现性好,可用于硫酸奈替米星注射液中奈替米星的含量测定。

OBJECTIVE To establish a HPLC method for the determination of netilmicin sulfate injection of netilmicin. METHODS The chromatographic condition included Hypersil BDS C18 （4. 6 × 250mm,5 μm）, the mobile phase was composed of 0. 05mol·L-1 trifluoroacetic acid and methanol（80： 20）, the flow rate was 1mL·min- 1, the detection was 205nm, column temperature was 30℃. RESULTS Netilmicin and other related substances were weU separated, in 10. 15μg - 50. 75 μg range with a good linear relationship between peak area（ r = 0. 9996） ; the average recovery was 99.61% ,RSD was 1% （n =9） ,had no effect on the detectionof accessories. Compared with the titer of law, there was no significant difference method. CONCLUSION This method is quick and simple, accurate,reproducible, and can be used for netilmicin sulfate injection in the contentdetermination of netilmicin.