应用亲水作用色谱技术同时测定赖氨葡锌口服液中两有效成分的含量

发布时间：2018-07-16 09:22

【摘要】：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。
[Abstract]:Objective: to establish a method for simultaneous determination of zinc gluconate and lysine hydrochloride in leigastrin oral liquid by hydrophilic interaction chromatography (HILIC). Methods: the chromatographic column was Inertsil Amide column (250mm 脳 4.6mm ~ 5 渭 m),) with phosphate buffer solution (potassium dihydrogen phosphate 2.72 g, sodium octanesulfonate 0.46 g, water 1 000 mL dissolved) -acetonitrile (32:68) as mobile phase, and phosphate buffer solution (potassium dihydrogen phosphate 2.72%). G, sodium octanesulfonate 0.46 g, dissolved in water 1 000 mL) -acetonitrile (95:5) as mobile phase B (gradient elution 0 ~ 2 min ~ 100 min) and a gradient elution of 0 ~ 2 min ~ (2 min) ~ 100 min ~ (100) A ~ (10) A ~ (100) B ~ (1517) ~ 100 ~ (17) min ~ 100B), the detection wavelength was 203 nm and the column temperature was 30 鈩，

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