高效液相色谱法同时测定呋塞米片中6种有关物质  

Simultaneous determination of 6 related substances in Furosemide Tables by high performance liquid chromatography

作　　者：邵雪力 康冰莹 费佳 刘健 SHAO Xueli;KANG Bingying;FEI Jia;LIU Jian(Zhoukou Product Quality Inspection and Testing Center,Zhoukou 466000,China;Zhoukou Drug Alert Center,Zhoukou 466000,China)

机构地区：[1]周口市产品质量检验检测中心,河南周口466000 [2]周口市药物警戒中心,河南周口466000

出　　处：《化学分析计量》2024年第10期68-73,共6页Chemical Analysis And Meterage

摘　　要：建立高效液相色谱法同时测定呋塞米片中6种已知杂质,考察了分析方法的专属性、线性范围、灵敏度、准确度、精密度、稳定性及不同定量方式计算相同样品的差异。结果表明,呋塞米和6种已知杂质的质量浓度在1.0~12.0μg/mL范围内与对应的色谱峰面积线性关系良好,相关系数大于0.999,且6种已知杂质的3种浓度水平加标回收率为95.2%~101.9%,测定结果的相对标准偏差均低于6.5%。该方法简便、快速,专属性强,准确度与精密度较好,可用于呋塞米片的质量控制。A high performance liquid chromatography method was established for simultaneous determination of 6 known related substances in Furosemide Tablets,and characteristics of this method were investigated,including that specificity,linear range,sensitivity,accuracy,precision,stability and result difference of the same sample through calculation of different quantitative method.The concentration of furosemide and its 6 known related substances had better linear relationship with corresponding chromatographic peak area in the range of 1.0-12.0μg/mL,and the correlation coefficients were greater than 0.999.The recovery rates of three concentration levels of 6 known related substances were between 95.2%and 101.9%,the relative standard deviation of the determination results were less than 6.5%.This method is simple,rapid,and has strong specificity,good accuracy and precision,which can be used for quality control of furosemide tablets.

关 键 词：高效液相色谱法 呋塞米片 有关物质 质量控制 

分 类 号：O657.7[理学—分析化学]