HPLC-ELSD测定注射液中泰拉霉素的含量

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ODS C₁₈(250 μm×4.6 μm,5 μm)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1 mL/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172.4 kpa,增益为150。研究结果表明,泰拉霉素在0.01~0.2 mg/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。

Determination of Tulathromycinin in Injection by HPLC-ELSD Method

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 tulathromycin. The chromatographic condition were ODS C₁₈(250 μm×4.6μm,5 μm).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-scattering 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 96.3% 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 injection.