中国处方药2024,Vol.22Issue(9) :34-37.

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

莫韵斯 王俊尹 李玮玲 伍良涌
中国处方药2024,Vol.22Issue(9) :34-37.

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

莫韵斯 1王俊尹 1李玮玲 1伍良涌1
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作者信息

  • 1. 广州市药品检验所,广州 510160
  • 折叠

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,C18 色谱柱(250 mm×4.6 mm,5 μm);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 0.001~2.067 μg/ml范围内与峰面积呈良好的线性关系,线性相关系数r为 0.999 9;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.

Abstract

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 C18 column(250 mm×4.6 mm,5 μm)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 0.001~2.067 μg/ml(r=0.999 9).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

Key words

Calcium and zinc gulconates oral solution/Determination of 5-hydroxymethyl furfural/HPLC/Quality control

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基金项目

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)

出版年

2024
中国处方药
南方医药经济研究所

中国处方药

影响因子:0.649
ISSN:1671-945X
参考文献量13
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