| 摘要: |
| 目的 通过分析右美沙芬愈创甘油醚糖浆中的有关物质和5-羟甲基糠醛含量，研究右美沙芬愈创甘油醚糖浆内在质量。方法 采用HPLC测定11批次右美沙芬愈创甘油醚糖浆中的有关物质和5-羟甲基糠醛。以Agilent Zorbax Bonus-RP（4.6×250mm，3.5μm）为分析柱，0.2%三氟乙酸溶液和乙腈梯度洗脱，检测波长278nm，测定主成分和各杂质。根据原辅料强制破坏试验和糖浆的加速试验，考察各杂质变化情况并分析影响因素。结果 主成分和各杂质分离良好，杂质在各自浓度范围内线性相关系数均大于0.9994，回收率大于95%。糖浆pH值低、包装遮光不足的样品，杂质增长较快。结论 应注意控制右美沙芬愈创甘油醚糖浆的pH值，并使用遮光材料包装，减少因pH值过低和遮光不足而导致杂质增加。 |
| 关键词: 右美沙芬愈创甘油醚糖浆 有关物质 5-羟甲基糠醛 |
| DOI：10.13748/j.cnki.issn1007-7693.20231117 |
| 分类号: |
| 基金项目:国家药品抽检计划项目(国药监药管[2021]1号，编号82) |
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| Study on the Related Substances and 5-hydroxymethylfurfural in Dextromethorphan Hydrobromide and Guaifenesin Syrup |
|
TANG Lichao
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|
Xiamen Institution for Food and Drug Quality Control
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| Abstract: |
| ABSTRACT: OBJECTIVE To investigate the quality of dextromethorphan guaifenesin syrup by observing the content of related substances and 5-hydroxymethylfurfural (5-HMF) in the syrup. METHODS The related substances and 5-HMF in 11 batches of dextromethorphan hydrobromide and guaifenesin syrup were determined by HPLC. The separation was performed on Agilent Zorbax Bonus-RP column (4.6×250mm, 3.5μm) with gradient elution of 0.2% trifluoroacetic acid solution (mobile A)- acetonitrile (mobile B) at a detection wavelength of 278 nm. Investigated the changes of impurities and analyzed the influencing factors according to the forced destruction test of raw materials and the accelerated test of syrup. RESUTLS The principal component and each impurity were adequately separated. The correlation coefficient of each impurity was more than 0.9994 and the recovery was greater than 95%. The impurities increased significantly in products with low pH and insufficient packaging shading. CONCLUSION The content of degradation impurities in dextromethorphan guaifenesin syrup was impacted by pH and packaging materials. It is suggested that the pH of dextromethorphan hydrobromide and guaifenesin syrup should be controled and shading materials package should be used to reduce the increase of impurities. |
| Key words: dextromethorphan hydrobromide and guaifenesin syrup related substances 5-HMF |
