反相高效液相色谱法测定盐酸美普他酚(2-氨基-6-甲基)-苯甲酸酯的含量

Determination of the content of meptazinol(2-amino-6-methyl)-benzoate hydrochloride by RP-HPLC

目的建立反相高效液相色谱法（reversed phase-high performance liquid chromatography,RP-HPLC）测定盐酸美普他酚（2-氨基-6-甲基）-苯甲酸酯的含量。方法采用C18（4.6 mm×150 mm,5μm）色谱柱,0.02 mol/L醋酸铵水溶液（氨水调节pH至7.4）：甲醇（25∶75,V/V）为流动相,流速1.0 mL/min,检测波长230 nm,柱温30℃。结果盐酸美普他酚（2-氨基-6-甲基）-苯甲酸酯的最低定量限为20 ng,线性范围20-500μg/mL（r=0.999 4）。结论本方法简便、灵敏、准确,可用于盐酸美普他酚（2-氨基-6-甲基）-苯甲酸酯的质量控制。

Objective To establish a reversed phase-high performance liquid chromatography（RP-HPLC） method to determine the content of meptazinol（2-amino-6-methyl）-benzoate hydrochloride.Methods A C18（4.6 mm×150 mm,5 μm） column was used with the mobile phase of 0.02 mol/L ammonium acetate（pH adjusted to 7.4 with aqueous ammonia）： methanol（25 ∶ 75,V/V）,the flow rate of 1.0 mL/min,the UV-detector at the wavelength of 230 nm,and the column temperature of 30 ℃.Results The limit of detection for meptazinol（2-amino-6-methyl）-benzoate hydrochloride was 20 ng.Good linearity was demonstrated at the range of 20-500 μg/mL（r=0.999 4）.Conclusions The established method was proved to be simple,sensitive and accurate.It can be used for the quality control of meptazinol（2-amino-6-methyl）-benzoate hydrochloride.