高效液相色谱法测定薏辛除湿止痛胶囊中乌头碱限量  

Determination of Aconitine Limits in Yixin Chushi Zhitong Capsules by HPLC

作　　者：田京歌 冯有龙 TIAN Jingge;FENG Youlong(Jiangsu Institute for Food and Drug Control,Nanjing Jiangsu 210019,China)

机构地区：[1]江苏省食品药品监督检验研究院,江苏南京210019

出　　处：《药品评价》2021年第21期1286-1288,共3页Drug Evaluation

摘　　要：目的:建立HPLC法用于测定薏辛除湿止痛胶囊中乌头碱限量。方法:采用Waters Atlantis T3 C18色谱柱(5 μm,4.6 mm×250 mm);采用甲醇-0.04 mol/L三乙胺(使用磷酸溶液调节pH至3.0±0.1)(40∶60)为流动相,检测波长设为235 nm,设定1.0 mL/min的流速;进样量为20 μL;柱温采用40 ℃。结果:乌头碱的线性范围为1.09~21.8 μg/mL,在此范围内线性关系良好(r=0.999 9),所得到的检测限是0.333 mg/kg。结论:建立的方法稳定性好,准确简单,可用于薏辛除湿止痛胶囊中乌头碱限量检查。Objective:To develop a HPLC method to determine the limits of aconitine in yixin chushi zhitong capsules.Methods:A Waters Atlantis T3 C18 column (5 μm,4.6 mm×250 mm) was used for the HPLC assay.Methanol-0.04 mol/L triethylamine (adjusting pH to 3.0±0.1 with phosphoric acid) (40∶60) was used as the mobile phase.The detection wavelength of 235 nm was used.The flow rate was 1.0 mL/min,the injection volume of 20 μL was used and the column temperature of 40 ℃ was used.Results:A good linear relationship (r=0.999 9) of aconitine was in the range of 1.09~21.8 μg/mL,and 0.333 mg/kg was as the detection limit.Conclusion:The method is stable,accurate,simple,and can be used to check the limits of aconitine in yixin chushi zhitong capsules.

关 键 词：高效液相色谱法 薏辛除湿止痛胶囊 乌头碱 

分 类 号：R286.0[医药卫生—中药学]