【摘要】：目的:應(yīng)用親水作用色譜(HILIC)技術(shù),建立可同時測定賴氨葡鋅口服液中葡萄糖酸鋅和鹽酸賴氨酸含量的方法。方法:色譜柱為Inertsil Amide柱(250 mm×4.6 mm,5μm),以磷酸鹽緩沖液(取磷酸二氫鉀2.72 g,辛烷磺酸鈉0.46 g,加水1 000 mL使溶解)-乙腈(32∶68)為流動相A,以磷酸鹽緩沖液(取磷酸二氫鉀2.72 g,辛烷磺酸鈉0.46 g,加水1 000 mL溶解)-乙腈(95∶5)為流動相B,(梯度洗脫,0~2 min,100%A;2~15 min,100%A→100%B;15~17 min,100%B),檢測波長203 nm,柱溫30℃。結(jié)果:在選定的色譜條件下,葡萄糖酸鋅峰和賴氨酸峰分離度良好,葡萄糖酸鋅和鹽酸賴氨酸分別在0.364 8~3.648 1和0.406 5~4.605 0 mg·mL~(-1)濃度范圍內(nèi)具有良好的線性關(guān)系,平均回收率(n=3)在97.97%~101.97%之間。結(jié)論:建立的方法可有效控制賴氨葡鋅口服液的質(zhì)量,也可為質(zhì)量標(biāo)準(zhǔn)改進(jìn)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，

本文編號：2125942