中国药业2025，Vol.34Issue(11)：78-82,5.DOI:10.3969/j.issn.1006-4931.2025.11.016
高效液相色谱法同时测定保泰松片中4种色素含量
Simultaneous Determination of Four Pigments in Phenylbutazone Tablets by HPLC
摘要
Abstract
Objective To establish a high-performance liquid chromatography(HPLC)method for simultaneous determination of four artificially synthetic pigments(carmine red,lemon yellow,amaranth red,and temptations red aluminum lake)in Phenylbutazone Tablets.Methods The chromatographic column was Waters Symmetry Shield C18 column(250 mm×4.6 mm,5 μm),the mobile phase was methanol-0.02 mol/L ammonium acetate solution(gradient elution),the flow rate was 1.0 mL/min,the detection wavelength was 254 nm,the column temperature was 35℃,and the injection volume was 10 μL.Results The linear range of carmine red,lemon yellow,amaranth red,and temptations red aluminum lake was 0.05-2.00 μg/mL(r≥0.999 6,n=7).The limit of detection was 0.02 μg/mL,and the limit of quantification was 0.05 μg/mL.The RSDs of the precision,stability,and repeatability test results were all lower than 1.5%.The average recoveries of carmine red,lemon yellow,amaranth red,and temptations red aluminum lake were 98.67%,97.96%,99.65%,and 99.72%,with RSDs of 1.09%,2.32%,1.50%,and 2.14%(n=6),respectively.The pigment components detected in eight batches of samples were consistent with the labeled pigment components,with a content of 3.77-40.56 mg/kg.Conclusion The established method has high accuracy,strong specificity,and high sensitivity,which can be used for the simultaneous determination of various artificially synthetic pigments in Phenylbutazone Tablets.关键词
高效液相色谱法/保泰松片/人工合成色素/含量测定Key words
HPLC/Phenylbutazone Tablets/artificially synthetic pigments/content determination分类
医药卫生引用本文复制引用
孙婷,闫凯,赵冬,王柳,朱嘉亮..高效液相色谱法同时测定保泰松片中4种色素含量[J].中国药业,2025,34(11):78-82,5.基金项目
河北省2021年度医学科学研究课题计划[20210108]. （）
