HPLC-ELSD法测定妥布霉素地塞米松滴眼液中妥布霉素的含量

Detemination of Tobramycin in Tobramycin Dexamethasone Eye Drops by HPLC-ELSD

目的：建立以高效液相色谱-蒸发光散射检测器法测定妥布霉素地塞米松滴眼液中妥布霉素含量的方法。方法：色谱柱为VP ODS C18，流动相为1．0％三氟乙酸-甲醇（95：5），流速为1．0mL·min^-1,载气漂移管温度为45℃，压力为3．5bar，检测波长为254nm。结果：妥布霉素检测浓度的线性范围为156．0-436．0μg·mL^-1（r=0．9997）；检测限和定量限分别为0．523、1．744μg；平均回收率为99．57％（RSD=0．92％）。结论：本方法准确可靠、专属性强，可用于该制剂的质量控制。

OBJECTIVE： To determine the content of tobramycin in Tobramycin Dexamethasone Eye Drops by HPLCELSD. METHODS： The sample was separated on VP- ODS C18 column. The mobile phase was 1.0% trifluoroacetic acid - methanol （95 ： 5） at a flow rate of 1.0 mL ·min^-1. The drift tube temprature was 45 ℃ ; the pressure of nebulizing gas was 3.5 bar, and the detection wavelength was set at 254 nm. RESULTS.： The liner range of tobramycin was 156.0-436.0μg ·mL^-1（ r = 0.999 7） . The limit of detection was 0.523μg and the limit of quantification was 1.744μg. The average recovery was 99.57% （RSD = 0.92%）. CONCLUSION： The method is accurate, reliable, specific, and suitable for the quality control of Tobramycin Dexamethasone Eye Drops.