Determination of the related substance in co-processed lactose and maize starch by ion chromatography
Wang Miao, Wang Caimei, Chen Ying
Guangdong Institute for Drug Control, Guangzhou 510663, China
摘要：建立离子色谱法测定乳糖玉米淀粉共处理物中的有关物质。采用离子色谱法( 安培检测器) 进行测定，
色谱柱为CarPac PA20 分析柱，流动相为水-氢氧化钠溶液（0.25 mol/L）-乙酸钠溶液（0.25 mol/L），梯度洗脱，流量为0.4 mL/min，柱温为30 ℃。蔗糖、葡萄糖、半乳糖、乳糖的质量浓度在0.05～2 μg/mL 范围内与色谱峰面积具有良好的线性关系，线性相关系数均大于0.999，检出限分别为0.01、0.005、0.01、0.01 μg/mL。测定结果的相对标准偏差为9.2%（n=6），样品加标回收率为92.1%～103.4%。采用所建方法对9 批供试品进行测定，其有关物质质量分数均不大于0.3%。该方法专属性强，灵敏度高，结果准确，可用于测定乳糖玉米淀粉共处理物中的有关物质。
Abstract：A method of determining the related substance in co-processed lactose and maize starch by ion chromatography was established. The related substance was determined by ion chromatography with amperometric detection.
CarPac PA20 column was used as the analytical column. The mixtures of pure water, 0.25 mol/L NaOH solution and
0.25 mol/L NaAC solution in different ratio were used as mobile phase in the gradient elution with the flow rate of 0.4 mL/min. The column temperature was 30 ℃. The mass concentration of sucrose, glucose, galactose, lactose and had a good linear relationship with the chromatographic peak area in the range of 0.05-2 μg/mL with the correlation coefficients all
more than 0.999, and the detection limits were 0.01, 0.005, 0.01, 0.01 μg/mL respectively. The relative standard deviation of the detection results was 9.2%(n=6), and the recoveries were 92.1%-103.4%. Nine lots of samples were determined by the established method, the contents of related substances were no more than 0.3%. The method has good specificity, sensitivity and accuracy, which can be used to determine the related substance in co-processed lactose and maize starch.
Keywords：co-processed lactose and maize starch; related substance; ion chromatography
王淼，王彩媚，陈英. 离子色谱法测定乳糖玉米淀粉共处理物中有关物质[J]. 化学分析计量，2021，30(3)：22.