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目的:针对苯溴马隆片现行标准中含量测定和有关物质检查的色谱系统中主峰与相邻杂质峰分离不理想的缺点,建立一个新的色谱方法,并对大组分杂质定性定位。方法:采用Agilent HC-C18色谱柱(250mm×4.6mm,5μm),流动相为冰醋酸-乙腈-水-甲醇(5∶25∶300∶990),检测波长为231nm。结果:在本文色谱条件下,主峰和杂质峰能得到良好的分离;在2.16～86.56μg.mL-1浓度范围内,峰面积与浓度呈良好线性关系,r=0.9997;平均回收率99.9%,RSD为0.86%(n=9)。结论:该法专属性强,灵敏、准确,耐用性好,可作为苯溴马隆片的质量控制方法。
OBJECTIVE: To establish a new chromatographic method for the determination of the content of benzbromarone in the chromatographic system, and to separate the main peak from the adjacent impurity peak in the standard system. Methods: The mobile phase was acetonitrile-water-methanol (5:25:300:990) with an Agilent HC-C18 column (250 mm × 4.6 mm, 5 μm). The detection wavelength was 231 nm. Results: Under the chromatographic conditions, the main peak and impurity peak can be well separated. The peak area and concentration showed a good linear relationship with the concentration range of 2.16 ~ 86.56μg.mL-1, r = 0.9997; the average recovery was 99.9% RSD was 0.86% (n = 9). Conclusion: The method is specific, sensitive, accurate and durable, and can be used as a quality control method for benzbromarone tablets.