高效液相色谱法测定琥珀酰明胶注射液中明胶的含量  

Determination of Gelatin in Succinylated Gelatin Injection by HPLC

作　　者：胡志远 张晓非[2] 王彦利[2] 

机构地区：[1]内蒙古赤峰艾克制药科技股份有限公司,内蒙古赤峰024000 [2]沈阳贝朗制药有限公司,辽宁沈阳110023

出　　处：《解放军药学学报》2006年第3期224-225,共2页Pharmaceutical Journal of Chinese People's Liberation Army

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。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- 12.0rag＇ 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.

关 键 词：琥珀酰明胶注射液 明胶 高敛液相色谱法 

分 类 号：R917[医药卫生—药物分析学]