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目的:建立高效液相色谱法测定右旋糖酐70甘油滴眼液中苯扎氯铵的含量。方法:以氰基硅烷键合硅胶为填充剂;以乙腈-0.03 mol.L-1磷酸二氢钠溶液(用1 mol.L-1氢氧化钠溶液调pH至7.0)(43∶57)为流动相;流速:2.0 mL.min-1;柱温:35℃;检测波长214 nm。苯扎氯铵C12、C14、C16之间的分离度应符合规定。结果:苯扎氯铵在1.28～3.00μg范围内与峰面积线性关系良好(r=0.9999,n=7);平均回收率(n=6)为100.9%,RSD=0.9%。结论:该法操作简便,快速、准确,灵敏度高,重复性好,可用于右旋糖酐70甘油滴眼液中苯扎氯铵含量测定。
Objective: To establish a method for the determination of benzalkonium chloride in dextran 70 glycerol eye drops by high performance liquid chromatography. Methods: Cyano-silane-bonded silica gel was used as a filler; acetonitrile-0.03 mol·L-1 sodium dihydrogen phosphate solution (pH = 7.0 with 1 mol·L-1 sodium hydroxide solution) Mobile phase; flow rate: 2.0 mL.min-1; column temperature: 35 ℃; detection wavelength 214 nm. Benzalkonium chloride C12, C14, C16 between the degree of separation should be consistent with the provisions. Results: The linear range of benzalkonium chloride was 1.28 ~ 3.00μg (r = 0.9999, n = 7). The average recovery was 100.9% (n = 6) and RSD was 0.9%. Conclusion: The method is simple, rapid, accurate, sensitive and reproducible. It can be used for the determination of benzalkonium chloride in dextran 70 glycerol eye drops.