【摘要】 目的建立高效液相色谱法测定琥珀酰明胶注射液中明胶的含量。方法采用高效液相色谱法,3根凝胶色谱柱串联,流动相为0.6%磷酸盐,流速0.8ml/min;进样量100μl;柱温:30℃;采用示差折光检测器。结果琥珀酰明胶在3.0~12mg·ml-1浓度范围内呈良好的线性关系,r=0.9999(n=5),平均回收率为99.58%,RSD=0.16%。结论本方法较紫外分光光度法更方便、快捷,且可与琥珀酰明胶注射液相对分子量及相对分子量分布测定同时进行,可作为中间产品的质量控制方法。更多还原

【Abstract】 Aim To establish an HPLC method for determination of Gelatin in Succinylated Gelatin Injection.Methods Three Water-Ultrohydrogel columns in series were used with the mobile phase of 0.6% phosphate solution and RI detector at the temperature of 30℃.Results The calibration curves of Gelatin were linear in the concentration range of 3.0～12.0mg·ml~ -1 (r=0.999 9).The average recoveries were 99.58%(RSD=0.16%).Conclusion This method is more user-friendly and efficient than the UV detector.Both Mn and Mn distribution can be determined simultaneously.This method can be used for quality control of semi-product.更多还原