测定地克珠利混悬液中的聚山梨酯20含量和枸橼酸含量的方法  

Method for Determination of Polysorbate20 and Citric Acid in Diclazuril Suspension

作　　者：李芳 孙立亚 杨丽英 LI Fang;SUN Li-ya;YANG Li-ying(Bimeda(Beijing)pharmaceutical Technology Co.Ltd.,Shijiazhuang 050000,China)

机构地区：[1]百美达医药科技(北京)有限公司,石家庄050000

出　　处：《中国兽药杂志》2024年第2期58-65,共8页Chinese Journal of Veterinary Drug

摘　　要：利用反相高效液相色谱法和蒸发光检测器快速便捷地测定地克珠利混悬液中聚山梨酯20和枸橼酸的成分及含量。吐温20方法:HPLC条件,Thermo U3000。流速:0.5 mL/min。流动相A:水,流动相B:乙腈。用梯度洗脱。ELSD 6000,漂移管温度:115℃。气体流速:2 L/min,稀释剂:乙腈。枸橼酸方法:橼酸的色谱条件:色谱柱:Tech Mate ST C18250 mm×4.6 mm,5μm,流动相:A;20 mmol磷酸氢二钠(用磷酸调节pH至3.0)B:色谱甲醇。流动相A∶B=95∶5。流速:1.0 mL/min,柱温:30℃紫外检测波长:UV 210 nm。该方法经过验证,有较好的精密度,线性及回收率等验证结果。该方法可以实现准确的定量分析,可作为一个可靠的检测方法。Rapid and convenient determination of excipients in Diclazuril suspension by HPLC and ELSD.(Tween 20 Method):HPLC condition,Thermo U3000.Flow rate:0.5 ml/min.Mobile phase A:water,Mobile phase B:acetonitrile.Gradient elution.ELSD 6000,drift tube temperature:115℃.Gas flow rate:2 L/min,diluent:acetonitrile.(Citric Acid Method)Column:Tech Mate ST C18250 mm×4.6 mm,5μm.Mobile phase A:20 mmol disodium hydrogen phosphate(adjust pH to 3.0 with phosphoric acid)water,Mobile phase B:Methanol Mobile phase:A∶B=95∶5.Flow rate:1.0 mL/min,Column temperature:30℃Wavelength:UV 210 nm.The method has been verified with good precision,linearity and recovery.The method can achieve accurate quantitative analysis.The method described in this paper can be used as a reliable detection method.

关 键 词：地克珠利 混悬液 聚山梨酯20 吐温20 枸橼酸 柠檬酸 

分 类 号：S859.79[农业科学—临床兽医学]