反相高效液相色谱法测定亮菌甲素琥珀酸单酯注射液含量

Content Determination of Principal Agent in Armillarisin Amber Acid Ester Injection by RP-HPLC

目的建立测定亮菌甲素琥珀酸单酯注射液中主药含量的高效液相色谱(HPLC)方法。方法以日本DL-Cl8柱(4.6mm×150mm,5μm)为色谱柱,甲醇-1%磷酸-三乙胺(45:55:0.05)为流动相,检测波长366nm,流速为0.8mL·min-1,采用HPLC法测定亮菌甲素琥珀酸单酯注射液中主药含量。结果亮菌甲素琥珀酸单酯注射液在浓度为1～100μg·mL-1范围内有良好的线性关系,相关系数为0.9999,精密度RSD为0.46%,平均加样回收率为102.25%,RSD为1.97%。结论该方法操作简单、快速、准确,可用于亮菌甲素琥珀酸单酯注射液中亮菌甲素琥珀酸单酯的含量测定。

Objective To establish a RP-HPLC method for detecting the principal agent in armillarisin amber acid ester （AAAE） injeetion. Methods RP-HPLC was performed on DL-C18 column（4.6 mm × 150 mm,5 μm） with methanol ： 1% phosphoric acid ： trietbylamine （45 ： 55 ： 0.05 ） as mobile phase at a flow rate of 0.8 mL · min^-1. The detection wavelength was 366 nm. Results The liner range of AAAE injection was 1 - 100 μg·mL^-1 , r = 0. 999 9. The relative standard deviation （RSD） for the method was 0.46% and 1.97%, respectively and the mean extraction recovery was 102.25%. Conclusion The method is proved to be accurate, sensitive and reliable, which is suitable for the determination of AAAE in the injection.