HPLC法测定硫酸奈替米星葡萄糖注射液的含量

Determination of netilmicin in Netilmicin Sulfate Glucose Injection by HPLC

目的采用高效液相色谱法测定硫酸奈替米星葡萄糖注射液中奈替米星的含量。方法采用十八烷基硅烷键合硅胶柱（4.6mm×150mm，5μm），以0.05mol·L^-1三氟醋酸溶液-丙酮（9：1），检测波长为205nm，流速为1.0mL·min^-1。结果奈替米星和有关物质分离度良好。奈替米星在25～400mg·mL^-1内呈良好的线性关系（r=0.9996），精密度试验RSD=0.59%，回收率为99.94%，系统适应性试验表明出峰时间，塔板数均良好，辅料对检测无影响。结论本方法快速，简便，结果准确可靠，重现性好。

OBJECTIVE To establish an HPLC method for the determination of netilmicin in Netilmicin Sulfate Glucose injection.METHODS The chromatographic condition included C18（4.6mm×150mm,5μm）column and mobile phase of 0.05mol·L^-1 trifluoroacetic acid-acetone（9∶1）.The flow rate was 1.0mL·min^-1 and the detection wavelength was 205nm.RESULTS Good separation of netilmincin and the related substances were achieved.The calibration curve was linear in the range of 25～400mg·mL^-1（r=0.9996）.The precision test was RSD 0.59%. The average recovery was 99.94%. The system adaptability experiment indicated the peak time and the number of plate was good,the supplementary material did not influence the test. CONCLUSION The method was simple and rapid,the results were accurate and reproducible.