摘要
目的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(5-hydroxymethylfurfural,5-HMF)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-HMF。以Agilent Zorbax Bonus-RP(4.6 mm×250 mm,3.5μm)色谱柱,0.2%三氟乙酸溶液(流动相A)和乙腈(流动相B)梯度洗脱,检测波长278 nm,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≥0.9994,回收率>95%。糖浆pH值低、包装遮光不足的样品,杂质增长较快。结论右美沙芬愈创甘油醚糖浆的pH值偏低及包装的遮光不足会导致降解杂质增加,应注意控制糖浆的pH值,并使用遮光材料包装,以减少糖浆中杂质的增长。
OBJECTIVE To analyze the content of related substances and 5-hydroxymethylfurfural(5-HMF)in dextromethorphan hydrobromide and guaifenesin syrup,and investigate the intrinsic quality of 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(4.6 mm×250 mm,3.5μm)column with gradient elution of 0.2%trifluoroacetic acid solution(mobile A)-acetonitrile(mobile B)at a detection wavelength of 278 nm to determine the principal components and various impurities.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.RESULTS The principal component and each impurity were adequately separated.The correlation coefficient of each impurity was≥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 is 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.
作者
唐立超
郑淑凤
TANG Lichao;ZHENG Shufeng(Xiamen Institution for Food and Drug Quality Control,Xiamen 361012,China)
出处
《中国现代应用药学》
CAS
CSCD
北大核心
2024年第16期2263-2269,共7页
Chinese Journal of Modern Applied Pharmacy
基金
国家药品抽检计划项目(国药监药管[2021]1号)。
关键词
右美沙芬愈创甘油醚糖浆
有关物质
5-羟甲基糠醛
dextromethorphan hydrobromide and guaifenesin syrup
related substances
5-hydroxymethylfurfural
