柱前衍生化-高效液相色谱法测定凝胶敷料中透明质酸钠含量  

Determination of sodium hyaluronate in gel dressing by precolumn derivatization high performance liquid chromatography

作　　者：崔萍 陈宁 商少华 曹庆丰 杨政 徐礼友 谷琴 CUI Ping;CHEN Ning;SHANG Shaohua;CAO Qingfeng;YANG Zheng;Xu Liyou;GU Qin(Jiangsu Provincial Institute of Material Medica,Nanjing 211816,China;Jiangsu Haizhi Biopharmaceutical Co.,Ltd.,Nanjing 211816,China)

机构地区：[1]江苏省药物研究所有限公司,南京211816 [2]江苏海智生物医药有限公司,南京211816

出　　处：《化学分析计量》2024年第7期47-54,84,共9页Chemical Analysis And Meterage

摘　　要：建立了一种柱前衍生化-高效液相色谱法测定透明质酸钠凝胶敷料中透明质酸钠的含量,可有效实现复杂组成透明质酸钠凝胶产品的质量控制。采用强酸将透明质酸钠凝胶敷料中的透明质酸钠水解成氨基葡萄糖和葡萄糖醛酸,利用1-苯基-3-甲基-5-吡唑啉酮与单糖还原性末端反应的原理,将氨基葡萄糖衍生化后,采用高效液相色谱法进行检测。采用Kromasil C_(18)柱分离,以乙腈-0.025 mol/L乙酸铵溶液(pH 4.5)作为流动相进行梯度洗脱,流速为1.0 mL/min,柱温为40℃。透明质酸钠的质量浓度在20~60μg/mL范围内与色谱峰面积线性关系良好,相关系数为0.9996,平均加标回收率为98.47%,测定结果的相对标准偏差为1.1%(n=9)。该方法受产品其他处方组成干扰影响小、准确度高、精密度好,可实现快速准确地测定复杂组成透明质酸钠凝胶敷料中的透明质酸钠的含量。A method for the determination of sodium hyaluronate in complex hydrogel dressing of sodium hyaluronate by high performance liquid chromatography-HPLC-column derivatization was established.The hydrogel dressing of sodium hyaluronate was hydrolyzed into aminoglucose and glucuronic acid with strong acid,based on the principle of 1-Phenyl-3-Methyl-5-pyrazolone and monosaccharide reducing end reaction,amino sugar was derived and detected by HPLC.Kromasil C_(18) column was used for separation,acetonitrile and 0.025 mol/L ammonium acetate solution(pH 4.5)were used as mobile phase for gradient elution,the flow rate was 1.0 mL/min,the column temperature was 40℃.The mass concentration of sodium hyaluronate in the range of 20-60μg/mL had a good linear relationship with peak area.The correlation coefficient was 0.9996,the average recovery rate was 98.47%,and the relative standard deviation was 1.1%(n=9).This method is less affected by other prescription components of the product,has high accuracy and precision,and can accurately and quickly determine the content of sodium hyaluronate in complex hydrogel dressing of sodium hyaluronate.

关 键 词：透明质酸钠 PMP衍生化 含量 高效液相色谱法 

分 类 号：O657.7[理学—分析化学]