SPE-HPLC测定小儿氨酚黄那敏颗粒中4种合成色素

Simultaneous Determination of 4 Synthetic Colors in Child Paracetamol, Artificial Cow-bezoar and Chlorphena Mine Maleate Granules by SPE-HPLC

关键词:  合成色素  高效液相色谱法  固相萃取

Key words:  synthetic colors  HPLC  solid-phase extraction(SPE)

摘要:

目的 建立小儿氨酚黄那敏颗粒剂中合成色素的SPE-HPLC测定方法。方法 使用SPE固相萃取柱对合成着色剂进行净化、富集；采用HPLC测定含量。色谱柱为Inertsil ODS-3 C₁₈柱(4.6 mm×250 mm，5 μm)；以甲醇-0.02 mol·L^-1乙酸铵溶液为流动相，梯度洗脱；检测波长为各自的最大吸收波长(柠檬黄428 nm，日落黄521 nm，胭脂红509 nm，苋菜红483 nm)；柱温30 ℃；进样量10 μL；流速1.0 mL·min^-1。结果 柠檬黄、日落黄、苋菜红和胭脂红在0.05~4 μg·mL^-1内呈良好线性关系(r≥0.999 5)，平均回收率分别为98.0%，97.9%，98.6%和99.5%，RSD均<0.9%。结论 该法操作简便、准确、重复性好，可用于同时测定小儿氨酚黄那敏颗粒中的4中合成色素。

Abstract:

OBJECTIVE To develop a solid-phase extraction (SPE)-high performance liquid chromatographic( HPLC ) method for the simultaneous determination of tartrazine, sunset yellow, ponceau 4RC and amaranth in Child Paracetamol, Artificial Cow-bezoar and Chlorphena Mine Maleate granules. METHODS The granule sample was dissolved in water, and the solution was purified and enriched by a polyamide SPE column. The eluate obtained was analyzed by HPLC method with Inertsil ODS-3 C₁₈ column(4.6 mm×250 mm, 5 μm), methanol-0.02 mmol·L^-1 ammonium acetate solution as mobile phase with gradient elution. For quantitative analysis, the detection was performed at the maximum absorption of the synthetic colors, they were 428 nm(tartrazine), 521 nm (sunset yellow), 509 nm (ponceau 4RC) and 483 nm (amaranth). The column temperature was 30 ℃ and the flow rate was 1.0 mL·min^-1. RESULTS The linear ranges of tartrazine, sunset yellow, ponceau 4RC and amaranth were 0.05-4 μg·mL^-1(r≥0.999 5). The average recoveries were 98.0%(RSD=0.52%), 97.9%(RSD=0.38%), 98.6% (RSD=0.27%) and 99.5% (RSD=0.43%), respectively. CONCLUSION The method is simple, accurate, and reproducible, can be used for the quality control of 4 synthetic colors in Child Paracetamol, Artificial Cow-bezoar and Chlorphena Mine Maleate granules.