葡萄糖酸钙锌口服溶液中5-羟甲基糠醛含量测定方法研究  

Study on the determination of 5-hydroxymethyl furfural in calcium and zinc gulconates oral solution

作　　者：莫韵斯 王俊尹 李玮玲[1] 伍良涌[1] MO Yun-si;WANG Jun-yin;LI Wei-ling(Guangzhou Institute for Drug Control,Guangzhou 510160,China)

机构地区：[1]广州市药品检验所,广州510160

出　　处：《中国处方药》2024年第9期34-37,共4页Journal of China Prescription Drug

基　　金：广州市市场监督管理局科技项目(2022kj31);广东省药品监督管理局科技项目(2023TDB15)。

摘　　要：目的针对葡萄糖酸钙锌口服溶液中5-羟甲基糠醛(5-HMF)检查方法进行研究,建立干扰小、定量准确的测定方法。方法采用高效液相色谱法,C_(18)色谱柱(250 mm×4.6 mm,5μm);以0.05 mol/L磷酸二氢钾溶液(用磷酸调节pH值至3.5)为流动相A,乙腈为流动相B,梯度洗脱,流速1.0 ml/min,检测波长284 nm。结果5-羟甲基糠醛在0.001~2.067μg/ml范围内与峰面积呈良好的线性关系,线性相关系数r为0.9999;检测限为0.207 ng/ml,定量限为0.689 ng/ml;平均回收率为99.4%,RSD范围为0.5%(n=6)。结论本法可用于葡萄糖酸钙锌口服溶液中5-羟甲基糠醛的限量检查,可为该品种质量标准提升提供参考。Objective To study the determination of 5-hydroxymethyl furfural in calcium and zinc gulconates oral solution,and establish a suitable method with less interference and quantitative accuracy.Methods HPLC with C_(18) column(250 mm×4.6 mm,5μm)was adopted,the mobile phase consisted of 0.05 mol/L potassium dihydrogen phosphate solution(adjust pH to 3.5 with phosphoric acid)as mobile phase A,acetonitrile as mobile phase B-acetonitrile at a flow rate of 1.0 ml/min by gradient eluting.The detective wavelength was 284 nm.Results The calibration curve of 5-hydroxymethyl furfural was in good linearity over the range of 0.001~2.067μg/ml(r=0.9999).The limit of detection(LOD)was 0.207 ng/ml and the limit of quantification(LOQ)was 0.689 ng/ml.The average recovery was 99.4%with an RSD of 0.5%(n=6).Conclusion The method can be used for limit detection of 5-hydroxymethyl furfural in calcium and zinc gulconates oral solution and gives a reference to the improvement of its standard.

关 键 词：葡萄糖酸钙锌口服溶液 5-羟甲基糠醛检查 HPLC法 质量控制 

分 类 号：R927.2[医药卫生—药学]