固相萃取-超高效液相色谱法测定愈酚喷托异丙嗪颗粒中6种色素含量  

Simultaneous Determination of 6 Pigments in Sulfogaiacol,Pentoxyverine and Promethazine Granules by Solid Phase Extraction-Ultra Performance Liquid Chromatography

作　　者：江舸 朱恒怡 谢华 常艳波 吴强 Jiang Ge;Zhu Hengyi;Xie Hua;Chang Yanbo;Wu Qiang(Department of Chemical Laboratory,Sichuan Institute for Drug Control,Chengdu 610097,China;Department of Bioanalytical Service Center,Sichuan Institute for Drug Control,Chengdu 610097,China;Department of Business,Sichuan Institute for Drug Control,Chengdu 610097,China)

机构地区：[1]四川省药品检验研究院化学药品所,成都610097 [2]四川省药品检验研究院生物样本检测中心,成都610097 [3]四川省药品检验研究院业务科,成都610097

出　　处：《成都医学院学报》2022年第4期434-437,共4页Journal of Chengdu Medical College

摘　　要：目的建立超高效液相色谱法同时测定愈酚喷托异丙嗪颗粒(SPPG)中可能存在的6种色素(胭脂红、日落黄、新红、苋菜红、诱惑红、偶氮玉红)的含量。方法采用固相萃取法对样品进行前处理后,超高效液相色谱法测定含量。使用美国沃特世HSS T3色谱柱(50 mm×2.1 mm,1.8μm),以10 mmol/L磷酸二氢铵溶液为流动相A,甲醇为流动相B,梯度洗脱,流速0.5 mL/min,柱温30℃,检测波长254 nm。结果样品中的其他成分均不干扰6种色素的检测,6种色素均能达到基线分离,在相应浓度范围内均呈现良好的线性关系,相关系数均不小于0.9996,该方法精密度、重复性、回收率均良好。对12个厂家132批样品中的合成色素进行测定,结果胭脂红含量为0.03~0.16 g/kg,9个厂家存在未按处方投料的情况,日落黄、新红、苋菜红、诱惑红、偶氮玉红均未检出。结论该方法快速、准确、重复性好,可用于SPPG中红色色素的质量控制。Objective To establish a solid phase extraction-ultra performance liquid chromatography(SPE-UPLC)method for simultaneous detection of 6 pigments(neucoccin,sunset yellow,new red,amaranth,allura red and azorubin)in Sulfogaiacol,Pentoxyverine and Promethazine Granules(SPPG).Methods Sample solution was prepared by SPE method and then determined by UPLC.An ACQUITY UPLC HSS T3 column(50 mm×2.1 mm,1.8μm)from American Waters company was used.The mobile phases A was 10 mmol/L ammonium dihydrogen phosphate,the mobile phase B was methanol,and 6 synthetic colorants were detected with gradient elution.The flow rate was set at 0.5 mL/min,the column temperature was 30℃,and the detection wavelength was at 254 nm.Results The 6 pigments were separated completely from the other substances and achieved the baseline separation,showing a good linear relationship in their respective concentration ranges.And the correlation coefficients were not less than 0.9996.The precision,repeatability and recovery of the method were good.The synthetic pigments in 132 batches of samples from 12 manufacturers were determined,and the results showed that the neucoccin content was 0.03-0.16 g/kg.There were 9 manufacturers who did not feed according to the prescription.The other 5 pigments were not detected in the samples.Conclusion The method was rapid,accurate and reproducible,and can be used for the quality control of red pigments in SPPG.

关 键 词：超高效液相色谱法 愈酚喷托异丙嗪颗粒 胭脂红 日落黄 新红 苋菜红 诱惑红 偶氮玉红 

分 类 号：R927.2[医药卫生—药学]