药用胶囊中6种合成色素高效液相色谱法的测定及不确定度  

Determination of 6 Synthetic Pigments in Medical Capsules by HPLC and Evaluation of Uncertainty

作　　者：刘惠霞 邓树强 LIU Hui-Xia;DENG Shu-Qiang(Department of Pharmacy,Huidong County People's Hospital,Huizhou 516300,China)

机构地区：[1]惠东县人民医院药剂科,广东惠州516300

出　　处：《中国药物经济学》2020年第2期41-46,共6页China Journal of Pharmaceutical Economics

基　　金：惠州市科技计划项目(2017Y247).

摘　　要：目的建立药用明胶空心胶囊中6种合成色素(柠檬黄、苋菜红、诱惑红、胭脂红、亮蓝、赤藓红)测定的高效液相色谱法(HPLC),并分析测得的不确定度。方法选择市场流通的1批明胶空心胶囊作为研究对象,建立6种合成色素的HPLC测定方法,并对不确定度进行分析。结果建立6种合成色素的HPLC测定方法,该法测定6种合成色素专属性良好,不受明胶干扰,在1~100μg/ml浓度范围内,峰面积与浓度线性相关,溶液在48 h内稳定,精密度和准确度符合样品分析要求,可用于6种人工合成色素的测定。空心明胶胶囊中存在柠檬黄、苋菜红、诱惑红、胭脂红、亮蓝、赤藓红残留,浓度分别为5.04、39.24、7.24、12.02、1.64和7.34μg/g。不确定度分析显示,该法测定合成色素的不确定度来源为样品称量和定容、HPLC测定、对照品溶液和重复测量,取置信概率为95%,k=2,6种合成色素测定的扩展不确定度分别为0.022、0.022、0.021、0.021、0.021和0.020μg/g。结论建立明胶空心胶囊中人工合成色素的HPLC含量测定方法,精密度和准确度均符合要求,试验过程中引入的不确定度小,方法简单、准确可靠。Objective establish the High Performance Liquid Chromatograph(HPLC)method to measure the 6 synthetic pigments(Lemon yellow,amaranth,tempting red,carmine,bright blue,and red peony)in medicinal gelatin hollow capsules,and to analyze its uncertainty.Methods One batch of gelatin hollow capsules circulating in the market was selected as the research object.HPLC methods for synthesizing 6 synthetic pigments were established,and the uncertainty was analyzed.Results HPLC method for the determination of 6 synthetic pigments was established,which had a good specificity for determining the 6 synthetic pigments and was not interfered by gelatin.The peak area was linearly correlated with the concentration in the concentration range of 1-100μg/ml,and the solution was stable within 48 hours.The accuracy and precision met the of analysis requirements and can be used for the determination of 6 artificical synthetic pigments.In the hollow gelatin capsules,there were residues of lemon yellow,amaranth,tempting red,carmine red,brilliant blue and red erythromycin with the concentrations 5.04,39.24,7.24,12.02,1.64 and 7.34μg/g,respectively.Uncertainty analysis showed that the sources of uncertainty of the method for the determination of synthetic pigments by this method was sample weighing and constant volume,HPLC determination,reference solution and repeated measurement.The confidence probability was 95%,k=2,and the extended uncertainty of 6 kinds of synthetic pigments is 0.022,0.022,0.021,0.021,0.021,and 0.020μg/g.Conclusion HPLC method for determination of synthetic pigments in gelatin hollow capsules is established.The precision and accuracy are in line with the requirements.The uncertainty introduced in the test process is small,and the method is simple,accurate and reliable,which is worthy of promotion.

关 键 词：明胶空心胶囊 合成色素 高效液相色谱法 不确定度 

分 类 号：R927.2[医药卫生—药学] O657.72[理学—分析化学]