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目的:建立测定硫酸锌尿囊素滴眼液中尿囊素含量的高效液相色谱方法。方法:采用Kromasil C18柱(150 mm×4.6 mm,5μm),流动相为0.03 mol.L-1的磷酸二氢钠溶液-甲醇(90∶10),检测波长为224nm,流速为1.0 mL.m in-1,外标法计算。结果:线性范围为50.6~1518.0 mg.L-1(r=0.9997,n=7),回收率为100.3%(RSD为1.51%,n=9)。结论:此方法快速简便,辅料无干扰,适用于该制剂的含量测定。
Objective: To establish a method for the determination of allantoin in alginate sulfate eye drops by high performance liquid chromatography. Methods: Kromasil C18 column (150 mm × 4.6 mm, 5 μm) was used. The mobile phase was 0.03 mol·L-1 sodium phosphate monobasic solution (90:10). The detection wavelength was 224 nm and the flow rate was 1.0 mL · m in-1, external standard calculation. Results: The linear range was 50.6-1518.0 mg.L-1 (r = 0.9997, n = 7). The recovery was 100.3% (RSD 1.51%, n = 9). Conclusion: This method is rapid and convenient, without interference of excipients and is suitable for the determination of the content of the preparation.