HPLC法测定新型兽用蒿甲醚注射液中蒿甲醚含量

摘要

To establish high performance liquid chromatography (HPLC)detection method for the determination of artemether in the artemether injection,the Hypersil ODS C18 chromatographic column (5 μm,4.6 mm × 150 mm) was used.The component of mobile phase,column temperature,flow rate and the detection wave length were optimized.The results showed that the acetonitrile-water-tetrahydrofuran (62∶ 37∶ 1,V/V)was as mobile phase,the column temperature was 30 ℃,the flow rate was 1.0 mL/min and the detection wavelength was set at 216 nm.The HPLC detection system adaptability of artemether was good.In 100-800 μg/mL concentration range,the linearity was well,the regression equation was y =302.36x-682.02,R2 =0.999 8.Overall average recovery was 97.58％ and RSD was 1.58％.RSD of 3 batches of samples of artemether content determination was 1.42％.The method could be used to detect the content of artemether in artemether injection.%为建立新型兽用蒿甲醚注射液中蒿甲醚含量的高效液相色谱测定方法,采用Hypersil ODS C18色谱柱(5μm,4.6 mm×150 mm),流动相为乙腈-水-四氢呋喃(体积比为62∶ 37∶1),柱温30℃,流速1.0 mL/min,检测波长216 nm.测定结果显示,蒿甲醚在该色谱条件下系统适应性好,在质量浓度为100 ～ 800 μg/mL时线性关系良好,回归方程为y=302.36x-682.02,R2=0.999 8;总平均回收率为97.58％,RSD为1.58％;对3批样品的蒿甲醚含量进行测定,RSD为1.42％.表明建立的方法可用于新型蒿甲醚注射液中蒿甲醚含量的测定.