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目的:建立一种邻苯二甲酸羟丙甲基纤维素酯的相对分子质量的质控方法。方法:采用高效凝胶渗透色谱法(HPG-PC),色谱柱为Styrage(Waters-HR4(7.8mm×300mm),以已知分子量的聚苯乙烯为标样,四氢呋喃为流动相;柱温40℃;流速1.0mL.min-1;示差折光检测器。结果:利用GPC软件处理得到邻苯二甲酸羟丙甲基纤维素酯的重均分子量,分子量分布和分布系数。结论:本文所建立HPGPC方法简便快速,重复性好(RSD<2%),适合于该类药物的质量控制。
Objective: To establish a quality control method for the relative molecular mass of hydroxypropylmethyl cellulose phthalate ester. Methods: High-performance gel permeation chromatography (HPG-PC) was used. The column was Styrage (Waters-HR4 (7.8mm × 300mm), using polystyrene of known molecular weight as standard and tetrahydrofuran as mobile phase. ℃, flow rate 1.0mL.min-1, refractive index detector.RESULTS: The weight average molecular weight, molecular weight distribution and distribution coefficient of hydroxypropyl methylcellulose phthalate were obtained by GPC software.Conclusion: HPGPC The method is simple, rapid and reproducible (RSD <2%) and is suitable for the quality control of these drugs.