摘要
目的:建立生脉饮(党参方)中果糖、葡萄糖、蔗糖、麦芽糖的高效液相色谱-示差折光(HPLC-RID)检测方法。方法:供试品以水为提取溶剂,采用Agilent 5 TC-C18色谱柱(250 mm×4.6 mm,5μm);流动相为乙腈-水(70∶30);柱温为45℃;流速为1.0 mL/min;示差折光检测器温度为40℃,并对收集的14批次样品进行检测。结果:果糖、葡萄糖、蔗糖、麦芽糖的线性范围分别为0.049~2.452 mg/mL(r=0.9993),0.090~4.503 mg/mL(r=0.9995),0.041~2.042 mg/mL(r=0.9997),0.070~3.524 mg/mL(r=0.9994);回收率(n=9)分别为98.21%、98.91%、95.82%、96.47%,RSD分别为1.1%、0.3%、2.3%、1.8%。结论:该方法准确性高、专属性强,可真实反映生脉饮(党参方)中蔗糖的实际投料情况。
Objective:To develop a HPLC-RID method for the determination of fructose,glucose,sucrose and maltose in shengmaiyin(dangshenfang).Methods:The test sample was extracted with water.The column was Agilent 5TC-C18 chromatographic column(250 mm×4.6 mm,5μm),the mobile phase was acetonitrile-water(70∶30),the column temperature was 45℃,the flow rate was 1.0 mL/min,the RID detector temperature was 40℃.14 batches of samples were tested.Results:The linear ranges for the detection of fructose,glucose,sucrose and maltose were 0.049-2.452 mg/mL(r=0.9993),0.090~4.503 mg/mL(r=0.9995),0.041-2.042 mg/mL(r=0.9997)and 0.070-3.524 mg/mL(r=0.9994)respectively.The average recoveries were 98.21%,98.91%,95.82%and 96.47%(n=9),and the RSDs were 1.1%,0.3%,2.3%and 1.8%,respectively.Conclusion:The method has high accuracy and specificity,and can truly reflect the actual addition of sucrose in shengmaiyin(dangshenfang).
作者
张璐
张土金
ZHANG Lu;ZHANG Tujin(Nanchang Inspection and Testing Center,Nanchang Jiangxi 330000,China;Shanggao County Maternal and Child Health Hospital,Shanggao Jiangxi 336400,China)
出处
《药品评价》
CAS
2022年第19期1161-1165,共5页
Drug Evaluation
基金
江西省药品监督管理局技术项目(2021KY25)。