摘要
目的建立反相高效液相色谱(RP-HPLC)法测定盐酸度洛西汀含量及其有关物质。方法色谱柱为美国Diamonsil(250 mm×4.6 mm,5μm)C18反相柱;流动相为乙腈-甲醇-缓冲液=30∶30∶40,流速为1.2 ml/min;检测波长230 nm。结果盐酸度洛西汀浓度在4.8～48.0μg/ml范围内,线性关系良好,标准曲线为A=5 147.5C+4.710 7(r=0.999 8,n=7),定量下限0.5μg/ml。结论 RP-HPLC法具有快速、简便、灵敏度高、重现性好等优点,可以用于盐酸度洛西汀的含量测定及有关物质检查。
[Objective]To establish a method for determination of Duloxetine hydrochloride and its related substances by RP-HPLC.[Methods]The column was Diamonsil C18（50 mm×4.6 mm,5 μm）,the mobile phase was acetonitrile： methyl alcohol： Buffer（30∶30∶40,V/V）,the flow rate was 1.2 ml/min,and the detection wavelength was 230 nm.[Results]Within a concentration range of 4.8-48.0 μg/ml,the linear relationship was good.The standard curve was A=5 147.5C＋4.710 7（r=0.999 8,n=7）,and the lower limit of quantification was 0.5 μg/ml.[Conclusion]RP-HPLC is a rapid and convenient method with high sensitivity and good reproducibility,and it can be used in determination of Duloxetine Hydrochloride and its related substances.
出处
《职业与健康》
CAS
2013年第10期1223-1225,共3页
Occupation and Health
