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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,5μm);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147.0～239.4μg.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 the determination of epinastine hydrochloride capsules and related substances. METHODS: ZORBAX SB-CN column (250 mm × 4.6 mm, 5 μm) was used as the mobile phase. The mobile phase consisted of acetonitrile-0.05 mol·L-1 phosphate buffer (6.8 g sodium dihydrogen phosphate dissolved in 1000 mL water, Triethylamine 3mL, shake, adjust pH to 4.5 ± 0.1 with phosphoric acid (35:65); flow rate 1.0 mL.min-1; detection wavelength was 220 nm; column temperature was 30 ℃. Results: Under the condition of the selected chromatographic conditions, the peak of the main peak was well separated from the related substances. The linear range of the epinastine hydrochloride was 147.0 ~ 239.4μg.mL-1 (r = 0.9999); the average recovery was 100.8 % (n = 9); detection limit was 0.5 ng. Conclusion: This method is specific, sensitive and simple and can be used to determine the content of epinastine hydrochloride capsules and related substances.