摘要
目的:建立硫酸妥布霉素注射液有关物质的测定方法。方法:采用高效液相色谱法,蒸发光散射检测器。色谱柱为C18柱,流动相为0.2mol.L-1三氟乙酸溶液,流速为0.4mL.min-1,飘移管温度为110℃,载气流量为3.0L.min-1。结果:妥布霉素检测浓度在0.14～1.01μg.mL-1范围内与峰面积积分值呈良好的线性关系(r=0.9954),妥布霉素与有关杂质能有效分离,检测限为0.1072μg。结论:本方法可有效地控制硫酸妥布霉素注射液中的有关物质。
OBJECTIVE：To establish a method for the determination of the related substance in Tobramycin sulfate injection.METHODS：HPLC method and evaporative light-scattering detector（ELSD）were adopted.The determination was performed on C18 column with mobile phase consisted of 0.2 mol·L-1 TFA solution at the flow rate of 0.4 mL·min-1.The drift tube temperature was set at 110 ℃,and flow rate of carrier gas was at 3.0 L·min-1.RESULTS：The linear range of tobramycin was 0.14～ 1.01 μg·mL-1（r=0.995 4）,and tobramycin and correlated impurity can be effectively separated.The detection limit was 0.107 2 μg.CONCLUSIONS：The method can effectively control the related substance in Tobramycin sulfate injection.
出处
《中国药房》
CAS
CSCD
2012年第16期1527-1528,共2页
China Pharmacy
