摘要
目的 建立分子排阻色谱法(SEC)测定玻璃酸钠滴眼液分子量及分子量分布,重点研究不同色谱条件及参数设置对测定结果的影响,并与日本药局方(18版)所用的特性粘数法进行比较。方法 采用分子排阻色谱法,色谱柱为Shodex SB806HQ(8.0 mm×300 mm),流动相为0.2 mol/L的氯化钠溶液(含0.02%ProClin300),流速为0.5 ml/min,柱温为35℃,进样量为100μl,采用示差折光检测器进行测定。结果 与特性粘数法比较,分子排阻色谱法不仅能测定平均分子量,还能同时用于分子量分布的控制,方法学验证结果表明该方法系统适用性、专属性、线性、精密度、准确度和耐用性良好,但不同切片参数的设置和凝胶渗透色谱(GPC)校准曲线的类型会对测定结果产生一定影响。结论 分子排阻色谱法可用于玻璃酸钠滴眼液分子量与分子量分布的控制,但建议在标准中明确切片参数的设置原则和GPC校准曲线的类型,以保证结果的准确性。
Objective To establish a method for the determination of molecular weight and molecular weight distribution of sodium hyaluronate eye drops using size exclusion chromatography(SEC),especially the impact of different chromatographic and parameter settings on the results,and comparing with the intrinsic viscosity method used in the Japanese Pharmacopoeia(18th edition).Methods Using size exclusion chromatography method,samples were analyzed on a Shodex SB806HQ(8.0 mm×300 mm);the mobile phase was 0.2 mol/L sodium chloride solution(containing 0.02%ProClin300)l at a flow rate of 0.5 ml/min;the column temperature was set at 35℃;the injection volume was 100μl,and the signals were detected by refractive index detector.Results Compared with the intrinsic viscosity method,size exclusion chromatography method can not only determine the average molecular weight,but also be used to control the molecular weight distribution.The results of methodological validation indicated that the method has good system adaptability,specificity,linearity,precision,accuracy,and robustness,although the setting of the method slicing parameters and the type of gel permeation chromatography(GPC)calibration curves may affect the determination results.Conclusion Size exclusion chromatography method can be used to control the molecular weight and molecular weight distribution of sodium hyaluronate eye drops,but it is recommended that the setting of slicing parameters and the type of GPC calibration curve be clarified in the specification to ensure the accuracy of the results.
作者
冯伟霞
房思思
聂双
谭惠敏
蔡文杰
邓永团
李晓峰
钟永亮
FENG Wei-xia;FANG Si-si;NIE Shuang(Mentholatum(China)Pharmaceutical Co.,Ltd.,Zhongshan 528400,China)
出处
《中国现代药物应用》
2025年第13期172-176,共5页
Chinese Journal of Modern Drug Application
关键词
玻璃酸钠滴眼液
分子量
分子量分布
分子排阻色谱法
Sodium hyaluronate eye drops
Molecular weight
Molecular weight distribution
Size exclusion chromatography
