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目的:应用亲水作用色谱(HILIC)技术,建立可同时测定赖氨葡锌口服液中葡萄糖酸锌和盐酸赖氨酸含量的方法。方法:色谱柱为Inertsil Amide柱(250 mm×4.6 mm,5μm),以磷酸盐缓冲液(取磷酸二氢钾2.72 g,辛烷磺酸钠0.46 g,加水1 000 mL使溶解)-乙腈(32∶68)为流动相A,以磷酸盐缓冲液(取磷酸二氢钾2.72 g,辛烷磺酸钠0.46 g,加水1 000 mL溶解)-乙腈(95∶5)为流动相B,(梯度洗脱,0~2 min,100%A;2~15 min,100%A→100%B;15~17 min,100%B),检测波长203 nm,柱温30℃。结果:在选定的色谱条件下,葡萄糖酸锌峰和赖氨酸峰分离度良好,葡萄糖酸锌和盐酸赖氨酸分别在0.364 8~3.648 1和0.406 5~4.605 0 mg·mL~(-1)浓度范围内具有良好的线性关系,平均回收率(n=3)在97.97%~101.97%之间。结论:建立的方法可有效控制赖氨葡锌口服液的质量,也可为质量标准改进提供新的研究思路。
OBJECTIVE: To establish a method for the simultaneous determination of zinc gluconate and lysine hydrochloride in Lysine, Glucose and Zinc Oral Liquid by using hydrophilic interaction chromatography (HILIC). METHODS: The column was an Inertsil Amide column (250 mm × 4.6 mm, 5 μm). Phosphate buffer (2.72 g potassium dihydrogen phosphate, 0.46 g sodium octane sulfonate and 1 000 mL water) was dissolved in acetonitrile 32:68) as mobile phase A, mobile phase B was consisted of phosphate buffer solution (2.72 g potassium dihydrogen phosphate, 0.46 g sodium octane sulfonate and 1 000 mL water) -acetonitrile (95: 5) Gradient elution, 0 to 2 min, 100% A; 2 to 15 min, 100% A to 100% B; 15 to 17 min, 100% B) at a detection wavelength of 203 nm with a column temperature of 30 ° C. Results: Under the selected chromatographic conditions, the peak of zinc gluconate and the peak of lysine were well resolved. The contents of zinc gluconate and lysine hydrochloride were 0.364 8 ~ 3.648 1 and 0.406 5 ~ 4.605 0 mg · mL ~ (- 1) has a good linear relationship within the concentration range, the average recovery (n = 3) between 97.97% ~ 101.97%. Conclusion: The established method can effectively control the quality of oral lysostazepine oral liquid, but also provide a new research idea for quality standard improvement.