摘要
目的考察市场上不同生产企业、不同级别聚山梨酯80中过氧化物含量及其影响因素,为药用辅料的评价和选择提供依据。方法采用柱前衍生化HPLC-UV法测定不同聚山梨酯80样品中过氧化物含量,采用SPSS软件对结果进行统计分析;考察高温、高湿和光照三个因素对聚山梨酯80中过氧化物含量的影响。结果在0.4875~22.75μg·mL^(-1)内,过氧化物浓度与峰面积呈良好的线性关系(r=0.9999),检测限0.01μg·mL^(-1),精密度和重复性RSD分别为1.0%、2.7%,平均回收率为100.2%,RSD为3.0%,方法的灵敏度高、准确度好。64批聚山梨酯80样品中过氧化物含量在15.54~172.64μg·g^(-1),均值58.60μg·g^(-1);不同生产企业、不同级别、国内外样品中过氧化物的量存在差异;高温、高湿和光照等因素均使聚山梨酯80中过氧化物含量增加,不同样品稳定性差异较大。结论柱前衍生化HPLC-UV法可用于聚山梨酯80中过氧化物的测定和比较,对产品质量更有区分力,可用于考察不同生产企业、不同级别样品的质量控制情况,为药品研发和生产企业选用优质药用辅料,提高药品的质量、安全性和稳定性提供参考和指导。
Objective To determine the content of peroxide in polysorbate 80 from different manufacturers and grades in the market and its influencing factors,to help evaluate and select pharmaceutical excipients.Methods The content of peroxide in different samples of polysorbate 80 was determined by precolumn derivatization HPLC-UV method.The results were analyzed with SPSS.The effects of high temperature,high humidity and light on the content of peroxide in polysorbate 80 were determined.Results Peroxide showed good linearity within 0.4875~22.75μg·mL^(-1)(r=0.9999).The detection limit was 0.01μg·mL^(-1),the RSDs of precision and reproducibility were 1.0%and 2.7%.The average recovery was 100.2%,with RSD was 3.0%.The sensitivity and accuracy of the method were good.The content of peroxide in the 64 sample batches ranged from 15.54μg·g^(-1)to 172.64μg·g^(-1),with an average of 58.60μg·g^(-1).The statistical analysis of the content of peroxide in the sample from different manufacturers,different grades and domestic and foreign sources all showed substantial differences.Factors such as high temperature,high humidity and light exposure all increased the peroxide content in polysorbate 80,and the stability of different samples varied greatly.Conclusion The precolumn derivatization HPLC-UV method can be used to determine and compare the content of peroxide in polysorbate 80 from different manufacturers and grades,to assess the quality and guide drug research and production enterprises to select high-quality pharmaceutical excipients.
作者
周颖
蒋贇
李昌亮
刘雁鸣
ZHOU Ying;JIANG Yun;LI Chang-liang;LIU Yan-ming(Hunan Institute for Drug Control,Changsha 410001;NMPA Key Laboratory for Pharmaceutical Excipients Engineering Technology Research,Changsha 410001)
出处
《中南药学》
2025年第8期2421-2427,共7页
Central South Pharmacy
基金
湖南省自然科学基金-科药联合基金项目(No.2023JJ60106)。
