HPLC法测定苯唑嗪胶囊中主成分及有关物质的含量
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篇名: HPLC法测定苯唑嗪胶囊中主成分及有关物质的含量
TITLE:
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 mL/min,检测波长为223 nm,柱温为25 ℃,进样量为20 μL。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20.04~60.12 μg/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。
ABSTRACT: 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 mL/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 were 0.91 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.
期刊: 2019年第30卷第19期
作者: 张英华,高佳,陈人萍,刘卫,王清,张炜煜
AUTHORS: ZHANG Yinghua,GAO Jia,CHEN Renping,LIU Wei,WANG Qing,ZHANG Weiyu
关键字: 苯唑嗪胶囊;高效液相色谱法;含量测定;有关物质
KEYWORDS: Phenzolzine capsules; HPLC; Content determination; Related substances
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