HPLC-ELSD测定妥布霉素滴眼液的含量  

Determination of Tobramycin Eye Drops by HPLC-ELSD

作　　者：刘咏梅[1] 

机构地区：[1]梅浙江省食品药品检验所,杭州310004

出　　处：《中国现代应用药学》2009年第7期590-593,共4页Chinese Journal of Modern Applied Pharmacy

摘　　要：目的建立高效液相色谱-蒸发光散射检测器检测法(HPLC-ELSD)测定妥布霉素滴眼液的含量。方法选用耐酸性的Agilent Zorbax SB-C18(4.6mm×250mm,5μm)色谱柱;流动相为0.2mol·L-1三氟乙酸溶液-甲醇(92:8),柱温为35℃,流速为0.8mL·min-1,进样体积为10μL;ELSD检测器漂移管温度为45℃,雾化气体压力为3.5bar,信号增益(GAIN)为5。结果妥布霉素在55.6～1396.7μg·mL-1内,其峰面积的对数与浓度的对数呈良好的线性关系(r=0.9997),检测限和定量限分别为0.15μg·mL-1和0.45μg·mL-1。结论方法专属性强,准确可靠,适用于妥布霉素滴眼液产品质量控制。OBJECTIVE To establish an HPLC - ELSD method for the content determination of tobramycin eye drops, METHODS In this method, the column was Agilent Zorbax SB - C18 （4.6 mm×250 mm, 5 μm）; The mobile phase consisted of 0.2 mol·L^-1 trifluoroacetatic acid solution-methanol （92 ： 8） at a flow rate of 0.8 mL·mL^-1. The drift tube temperature was set at 45 ℃, and the pressure of nebulizing gas was 3.5 bar. RESULTS The linear range was 55.6-1396.7 μg·mL^-1（r=0,999 7）, The limit of detection and quantification was 0.15/μg·mL^-1 and 0.45 μg·mL^-1 respectively. An average recovery of 99.0% with a RSD of 1.05% （n=9） was obtained. The precision for content determination of tobramycin was good （RSD = 0.8%, n=9）. CONCLUSION The method is simple, accurate and reliable. It is suitable for the routine quality control of tobramycin eye drops preparations.

关 键 词：妥布霉素 滴眼液 含量测定 高效液相色谱法 蒸发光散射检测器 

分 类 号：R917.101[医药卫生—药物分析学]