首页|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

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

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

Calcium and zinc gulconates oral solutionDetermination of 5-hydroxymethyl furfuralHPLCQuality control

莫韵斯、王俊尹、李玮玲、伍良涌

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广州市药品检验所,广州 510160

葡萄糖酸钙锌口服溶液 5-羟甲基糠醛检查 HPLC法 质量控制

广州市市场监督管理局科技项目广东省药品监督管理局科技项目

2022kj312023TDB15

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
年,卷(期):2024.22(9)