盐酸罗格列酮片中杂质A含量的方法学验证  

Methodological Verification of Impurity A in Rosiglitazone Hydrochloride Tablet

作　　者：郑媛媛 聂鹏 ZHENG Yuanyuan;NIE Peng(Guizhou Institute for Food and Drug Control,Guiyang 550004,China)

机构地区：[1]贵州省食品药品检验所,贵州贵阳550004

出　　处：《贵州大学学报（自然科学版）》2023年第3期41-46,共6页Journal of Guizhou University:Natural Sciences

基　　金：贵州省科技计划项目(黔科合基础-ZK[2021]一般041)。

摘　　要：经相关研究发现,某企业生产的盐酸罗格列酮片中含有少量的杂质A,其结构已表征和确认,为了满足人民安全用药的需求,有必要对其进行深入研究。通过高效液相色谱仪对盐酸罗格列酮片中杂质A的含量分析进行了方法学验证,其在1.13~9.06 ng范围内线性良好(r=0.9999),重复性相对标准偏差(relative standard deviation,RSD)为1.4%,检出限为0.45 ng,定量限为1.13 ng。此方法专属性强,线性适用范围相对较宽,稳定性好,检测结果较为准确,能够较好地分析盐酸罗格列酮片中杂质A的准确含量,可有效提升该品种的质量标准。It has been found that rosiglitazone hydrochloride tablets produced in an enterprise contain small amount of impurity A,whose structure has been characterized and confirmed.In order to meet the needs of people for safe drug use,it is necessary to conduct further research on it.The content of impurity A in rosiglitazone hydrochloride tablets was analyzed by high performance liquid chromatography.The results show that the content of impurity A in rosiglitazone hydrochloride tablets has good linearity(r=0.9999)in the range of 1.13~9.06 ng.The RSD of repeatability is 1.4%,and the detection limit and the quantitation limit is 0.45 ng,and 1.13 ng respectively.This method has strong specificity,relatively wide linear application range,good stability,and accurate detection results;it can better analyze the accurate content of impurity A in rosiglitazone hydrochloride tablets,and effectively improve the quality standard of this variety.

关 键 词：盐酸罗格列酮 杂质A 含量 方法学 

分 类 号：R917[医药卫生—药物分析学]