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复方薄荷脑苯酚搽剂质量标准研究
引用本文:陈燕霞,陈洁,黄樱华,丘振文,李得堂,黄月纯,孙亦群.复方薄荷脑苯酚搽剂质量标准研究[J].中国药业,2022(3):81-83.
作者姓名:陈燕霞  陈洁  黄樱华  丘振文  李得堂  黄月纯  孙亦群
作者单位:广州中医药大学第一附属医院
基金项目:广州中医药大学第一附属医院创新强院工程项目[2017ZWB10]。
摘    要:目的 建立复方薄荷脑苯酚搽剂中水杨酸和苯酚的定量分析方法.方法 采用紫外-可见分光光度法测定水杨酸的含量,检测波长为300 nm;采用高效液相色谱法测定苯酚含量,色谱柱为Agilent Zorbax SB-C18柱(250 mm×4.6 mm,5μm),流动相为甲醇-水(48:52,V/V),流速为1.0 mL/min...

关 键 词:复方薄荷脑苯酚搽剂  水杨酸  苯酚  含量测定  质量控制

Quality Standard of Compound Menthol Phenol Liniment
CHEN Yanxia,CHEN Jie,HUANG Yinghua,QIU Zhenwen,LI Detang,HUANG Yuechun,SUN Yiqun.Quality Standard of Compound Menthol Phenol Liniment[J].China Pharmaceuticals,2022(3):81-83.
Authors:CHEN Yanxia  CHEN Jie  HUANG Yinghua  QIU Zhenwen  LI Detang  HUANG Yuechun  SUN Yiqun
Institution:(The First Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou,Guangdong,China 510405)
Abstract:Objective To establish a method for the quantitative analysis of salicylic acid and phenol in Compound Menthol Phenol Liniment.Methods The content of salicylic acid was determined by the ultraviolet-visible(UV-Vis) spectrophotometry at the detection wavelength of 300 nm.The content of phenol was determined by the high-performance liquid chromatography(HPLC)method,the chromatographic column was Agilent Zorbax SB-C;column(250 mm×4.6 mm,5μm),the mobile phase was methanolwater(48-52,V/V),the flow rate was 1.0 mL/min,the column temperature was 25℃,the detection wavelength was 270 nm,and the injection volume was 10μL.Results The mass concentration of salicylic acid showed a good linear relationship with absorbance in the range of 0.005 1-0.030 4 mg/mL(r=0.999 2,n=6),the average recovery rate was 100.90% with an RSD of 0.69%(n=9).The injection volume of phenol showed a good linear relationship with absorbance in the range of 0.264 0-3.299 8μg(r=0.999 9,n=6),the average recovery rate was 100.54% with an RSD of 0.61%(n=9).The RSDs of precision,repeatability and stability tests of salicylic acid and phenol were less than 2%.Conclusion The method is simple,accurate,reproducible and stable,which can be used for the quality control of Compound Menthol Phenol Liniment.
Keywords:Compound Menthol Phenol Liniment  salicylic acid  phenol  content determination  quality control
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