HPLC-ELSD测定注射液中泰拉霉素的含量  

Determination of Tulathromycinin in Injection by HPLC-ELSD Method

作　　者：范炜达[1] 陈良柱[2] 贺利民[1] 方炳虎[1,2] 

机构地区：[1]华南农业大学兽医学院,广东广州510642 [2]广东大华农动物保健品股份有限公司,广东新兴527400

出　　处：《中国畜牧兽医》2012年第7期256-259,共4页China Animal Husbandry & Veterinary Medicine

基　　金：2010广州市科技支撑计划项目(2010Z1-E371)

摘　　要：本研究建立了注射液中泰拉霉素的高效液相色谱-蒸发光散射检测法。试样为自制5%泰拉霉素注射液,以ODSC18(250μm×4.6μm,5μm)为色谱柱,2 mmol/L乙酸铵水溶液(含0.1%甲酸)-乙腈(80∶20)为流动相,流速为1mL/min,柱温25℃,蒸发光散射检测器条件:漂移管温度60℃,喷嘴加热器级别为60%,气体压力为172.4kpa,增益为150。研究结果表明,泰拉霉素在0.01～0.2mg/mL范围内,呈良好的线性关系(R=0.9989),在高、中、低3个加标水平下的平均回收率为96.3%～97.8%,日间变异系数为0.6%～0.9%。该方法简便、快捷、准确,可用于泰拉霉素注射液的含量检测。A high performance liquid chromatograph-evaporative light-scattering detector（HPLC-ELSD） was developed for the content determination of tulathromycin in injection. The sample was injectable formulation containing 50 mg/mL tulathro- mycin. The chromatographic condition were ODS C18 （250 μm× 4.6μm,5μm）. The mobile phase was 0.02 mol/L ammonium acetate with formic acid-acetonitrile（80 ： 20）, flow rate was 1 mL/min; column temperature was 25 ℃ ; evaporative light-scat- tering detector（ELSD） ： drift tube temperature was 60℃; nebulizer heater level was 60% ; gas pressure was 172.4 kpa, PMT gain was 150. The calibration curve was linear in the range of 0. 01 to 0.2 mg/mL with correlation coefficient 0. 9989, the spiked recoveries at three spiked concentration levels were in the range of 96.30% to 97.8 %, the RSDs were 0.6% to 0.9%. The results showed that this method was simple, quick and accurate for the content determination of tulathromycin in injec- tion.

关 键 词：泰拉霉素 注射液 高效液相色谱-蒸发光散射检测法 含量测定 

分 类 号：S859.84[农业科学—临床兽医学]