HPLC法测定盐酸依匹斯汀胶囊的含量及有关物质

目的: 建立盐酸依匹斯汀胶囊含量和有关物质的HPLC测定方法。 方法: 采用ZORBAX SB-CN柱(250 mm×4.6 mm,5 μm);流动相为乙腈-0.05 mol·L^-1 磷酸盐缓冲溶液(取磷酸二氢钠6.8 g,溶解于1000 mL水中,精密加三乙胺3 mL,摇匀,用磷酸调pH至4.5±0.1)(35: 65);流速为1.0 mL·min^-1;检测波长为220 nm;柱温为30℃。 结果: 在该选定色谱条件下,主峰与有关物质峰分离度良好,盐酸依匹斯汀在147.0~239.4 μg·mL^-1 浓度范围内线性关系良好(r=0.9999);平均回收率为100.8%(n=9);检测限为0.5 ng。 结论: 该方法专属、灵敏、简便,可用于测定盐酸依匹斯汀胶囊的含量及有关物质。

Objective: To establish an HPLC method for determination of epinastine hydrochloride capsules and its related substances. Methods: The separation was performed on a ZORBAX SB-CN (250 mm×4.6 mm,5 μm) column with the mobile phase consisting of acetonitrile-0.05 mol·L^-1 phosphate solution (buffer solution:6.8 g of sodium dihydrogen phosphate was dissolved in 1000 mL water,3 mL of triethylamine was added exactly,the mixture was shaked and adjusted to pH 4.5±0.1 with phosphate acid)(35: 65) at the flow rate of 1.0 mL·min^-1.The detection wavelength was set at 220 nm The column temperature was 30℃. Results: Under the above conditions,the main peak and the peaks of the related stabstances were separated quite well.Epinastine hydrochloride capsules had a good linear relationship (r=0.9999) within the range of 147.0-239.4 μg·mL^-1.The average recovery (n=9) was 100.8%.The limit of the detection was 0.5 ng. Conclusion: The method is sensitive,specific and simple.It can be used for determining epinastine hydrochloride capsules and its related substances.

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