HPLC法测定苯唑嗪胶囊中主成分及有关物质的含量  

Determination of Main Components and Related Substances in Phenzolzine Capsules by HPLC

作　　者：张英华[1] 高佳 陈人萍[2] 刘卫[2] 王清[2] 张炜煜[1] ZHANG Yinghua;GAO Jia;CHEN Renping;LIU Wei;WANG Qing;ZHANG Weiyu(School of Pharmaceutical Sciences,Changchun University of TCM,Changchun 130117,China;Basic Institute of TCM,Jilin Provincial Academy of TCM,Changchun 130012,China)

机构地区：[1]长春中医药大学药学院,长春130117 [2]吉林省中医药科学院中医药基础所,长春130012

出　　处：《中国药房》2019年第19期2613-2617,共5页China Pharmacy

基　　金：国家科技重大专项重大新药创制项目(No.2011-ZX09102-003-03);吉林省科技发展计划项目(No.20170201003YY)

摘　　要：目的:建立测定苯唑嗪胶囊中主成分及有关物质含量的方法。方法:采用高效液相色谱法测定主成分含量,采用主成分自身对照法计算有关物质(已知杂质1、已知杂质2、总杂质)的含量。色谱柱为Inertsil ODS-2 C18,流动相为乙腈-水(55∶45,V/V),流速为1.0 m L/min,检测波长为223 nm,柱温为25℃,进样量为20μL。结果:苯唑嗪主成分与杂质分离度良好,苯唑嗪检测质量浓度线性范围为20.04~60.12μg/mL(r=1.000 0);精密度、稳定性(24 h)、重复性试验的RSD均≤0.5%(n=6);平均回收率为97.50%(RSD=0.36%,n=3);苯唑嗪的检测限和定量限分别为0.91、3.04 ng。在3批样品中,苯唑嗪、已知杂质1、已知杂质2、总杂质含量的平均值分别为106.68%、0.002 1%、0.044 0%、0.046 2%。结论:建立的苯唑嗪胶囊中主成分及有关物质的含量测定方法简便、专属性强、灵敏度高,结果准确,适用于苯唑嗪胶囊的质量控制。OBJECTIVE:To establish a method for content determination of main components and its related substances in Phenzolzine capsules. METHODS:HPLC method was adopted for content determination of main components. The contents of related substance(known impurity 1,known impurity 2,total impurity) were calculated with principle component self-control method. The determination was performed on Inertsil ODS-2 C18 column with mobile phase consisted of acetonitrile-water(55∶45,V/V)at the flow rate of 1.0 m L/min. The detection wavelength was set at 223 nm,and column temperature was 25 ℃. The sample size was 20 μL. RESULTS:The main component phenzolzine and other impurity peaks were well separated. The liner range of phenzolzine was 20.04-60.12 μg/mL(r=1.000 0). RSDs of precision,stability(24 h)and reproducibility tests were all ≤0.5%(n=6). Average recovery was 97.50%(RSD=0.36%,n=3). The detection limit and quantification limit of phenzolzine were0.91 ng and 3.04 ng. In 3 batches of samples,average value of phenzolzine,known impurity 1,known impurity 2 and total impurity were 106.68%,0.002 1%,0.044 0% and 0.046 2%,respectively. CONCLUSIONS:Established method is simple,specific,sensitive and accurate for content determination of main component and related substance in Phenzolzine capsules. It is suitable for quality control of Phenzolzine capsules.

关 键 词：苯唑嗪胶囊 高效液相色谱法 含量测定 有关物质 

分 类 号：R927.2[医药卫生—药学]