关于利巴韦林泡腾颗粒辅料中杂质的分析

Analysis of Impurities in the Excipients of Ribavirin Effervescent Granules

目的:建立液相-质谱联用测定法鉴别利巴韦林泡腾颗粒中的辅料,解决利巴韦林泡腾颗粒质量标准中有关物质杂质峰的判定问题。方法:采用高效液相色谱法对多个辅料进行初筛,初步断定杂质来源后用质谱法确证其结构及归属。结果:确定有关物质液相色谱图中保留时间约24 min的色谱峰为N-乙烯基吡咯烷酮,并确定杂质峰是从辅料聚维酮K30引入。结论:本研究建立液质联用法测定聚维酮K30中的N-乙烯基吡咯烷酮,操作简单,结果准确,为相关辅料的杂质确认和制剂标准的提高提供参考。

Objectives: to establish a liquid-mass spectrometry method to identify the excipients in ribavirin effervescent granules and solve the problem of determining the impurity peak of related substances in the quality standard of ribavirin effervescent granules. Methods: several excipients were screened by high performance liquid chromatography, the source of impurities was preliminarily determined, and their structure and attribution were confirmed by mass spectrometry.Results: the chromatographic peak with a retention time of about 24 min in the liquid chromatogram was determined to be N-Vinyl-2-Pyrrolidinone, and the impurity peak was determined to be introduced from the excipient povidone K30.Conclusions: This study established a LC-MS method for the determination of N-vinylpyrrolidone in povidone K30, which is simple and accurate. It provides a reference for the confirmation of impurities in related excipients and the improvement of preparation standards.