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目的:建立咪唑斯汀含量和有关物质测定的HPLC法。方法:采用高效液相色谱法,色谱柱为Zorbax-C18(4.6mm×250mm,5μm)。流动相为乙腈-0.02mol/L醋酸铵(40:60,pH4.0),流速为1.0mL/min,在220nm波长处检测。含量测定采用外标法,杂质检查采用面积归一化法。结果:本品与有关物质能较好分离,咪唑斯汀在0.01mg/mL～0.4mg/mL浓度范围内呈直线关系。结论:本方法专属性强,重复性好,可用于含量测定和杂质检查。
Objective: To establish HPLC method for the determination of mizolastine and related substances. Methods: High performance liquid chromatography (HPLC) was used. The column was Zorbax-C18 (4.6mm × 250mm, 5μm). The mobile phase was acetonitrile-0.02 mol / L ammonium acetate (40:60, pH 4.0) at a flow rate of 1.0 mL / min and detected at a wavelength of 220 nm. Determination of content using external standard method, impurity inspection using area normalization method. Results: This product and related substances can be better separation, mizolastine in the range of 0.01mg / mL ~ 0.4mg / mL showed a linear relationship. Conclusion: This method is highly specific and reproducible, and can be used for content determination and impurity inspection.