HPLC-ELSD测定硫酸依替米星氯化钠注射液中依替米星的含量

Determination of Etimicin Content in the Etimicin Sulfate Sodiam Chloride Injection by HPLC-ELSD

目的 建立高效液相色谱-蒸发光散射检测法测定硫酸依替米星氯化钠注射液中依替米星含量的方法.方法 采用ZORBAX SB C18(4.6 mm×250 mm,5 μm)色谱柱,以0.2 mol·L-1三氟乙酸-甲醇(84∶16)为流动相,SEDEX75蒸发光散色检测器,流速:0.6 mL·min-1,柱温:室温,柱压:93 bar, 检测器蒸发温度:41 ℃, 载气压力:3.5 bar, Gain:6, 进样量:20 μL.结果 本方法能分离依替米星及相关物质,依替米星浓度在0.06～1.0 mg·mL-1内呈良好的线性关系,r=0.999 7 (n=5), 平均回收率为(100.6±1.1)%(n=9).结论 本方法灵敏度高、专属性好,可用于硫酸依替米星氯化钠注射液中依替米星含量的测定.

OBJECTIVE To develop an HPLC-ELSD method for the determination of etimicin content in the etimicin sulfate sodiam chloride injection.METHODS The separation was performed on a ZORBAX SB C18(4.6 mm×250 mm,5 μm) with 0.2 mol·L-1 trifluoroacetic acid-methanol(84∶16) as mobile phase.The flow rate was set at 0.6 mL·min-1.Colomn temperature was room temperature,inlet heater was 41 ℃,gas pressure was 3.5 bar,Gain:6.RESULTS The linear range for the content of etimicin was 0.06～1.0 mg·mL-1,r=0.999 7(n=5).The recovery of etimicin was(100.6±1.1)%(n=9).CONCLUSION The method is good sensitive and suitable for the determination of etimicin content.