反相高效液相色谱法测定微量泵输液连接管中残留醋酸奥曲肽的浓度水平  

Research on determination of the concentration of octreotide acetate solution in infusion connection pipe by RP-HPLC method

作　　者：李苏芹 张宏文 吴金凤 肖旭东[2] 孙鲁宁[2] 

机构地区：[1]南京医科大学第一附属医院药学部,江苏南京210029 [2]中国药科大学,江苏南京210009

出　　处：《中国医学装备》2015年第10期23-26,共4页China Medical Equipment

基　　金：中国高校医学期刊临床专项资金(11210003)"醋酸奥曲肽在微量泵输液管中药液残留的解决方法探索"

摘　　要：目的：建立反相高效液相色谱（RP-HPLC）法测定微量泵输液连接管中残留醋酸奥曲肽的浓度，分析研究在冲管过程中连接管内醋酸奥曲肽溶液浓度水平的动态变化。方法：采用RP-HPLC法测定醋酸奥曲肽溶液浓度，色谱柱：Ultropac Column TSK ODS-120A（4.6 mm×250 mm，5μm）；流动相：0.3%四甲基氢氧化铵水溶液（内含0.0185%的三乙胺，用磷酸调pH值为6.0）；乙腈（108∶88）；流速为1.0 ml/min；柱温为35℃；检测波长为210 nm；进样量为40μl。采用模拟临床微量泵给药及常用输液连接管（容积为8.0 ml），泵药速度为6.3 ml/h，泵药结束后用适量溶媒冲管，对冲管前、冲管过程中不同时段泵出药液及冲管结束后管内残留药液分别取样；测定各取样点药液浓度，并计算泵出液浓度与配药原液浓度的比值（R）及R值的相对标准偏差（RSD）。结果：测定的醋酸奥曲肽浓度水平为0.1～6.4μg/ml，与峰面积呈良好的线性关系（r=0.9979）；定量限为0.4μg/ml，检测限为0.1μg/ml；加样回收率实验平均为96.9%，RSD值为2.2%。冲管过程中的前3/4时间里R值均＞90%，测定结果波动较小。结论：RP-HPLC测定方法速度快、灵敏度高，可用于微量泵输液连接管中醋酸奥曲肽溶液浓度的测定，测定结果可作为冲管操作的重要依据。Objective： To establish a RP-HPLC method for the determination of the content of octreotide acetate in octreotide acetate solution. To understand the dynamic change of octreotide acetate solution concentration in the process of punching tube. Methods： The concentration of the octreotide acetate solution was determined by RP-HPLC. Chromatographic conditions：Ultropac Column TSK ODS-120A（4.6 mm×250 mm, 5 μm）and 0.1%TFA water 0.1%TFA acetonitrile as the mobile phase at aflow rate of 1 ml/min were used with a column temperature of 35℃, a detection wavelength of 210 nm and an injection volume of 40 μl. Sampling method： Using simulated clinical micro pump injection, after the end of administration Flush the pipes with the same volume of solvent;Sampling to pump out liquid In the different periods in the process of washing pipe. The concentration of sample solution was determined and the ratio（R）of liquid concentration was calculated. Results： The standard curve of octreotide was linear in the range of 0.1~6.4 μg/ml, r=0.9979. The limit of quantification was 0.4 μg/ml, The detection limit was 0.1 μg/ml. The average recovery rate was 96.9%and RSD was 2.2%. Before the 3/4 time the concentration ratio of Sample solution（R）〉90%in the process of punching tube. Conclusion：The method is practicable and accurate and can be used for the Determination of the concentration of octreotide acetate solution. The results of determination can be used as the basis for operation method.

关 键 词：微量泵输液连接管 反相高效液相 醋酸奥曲肽 残留药液测定 

分 类 号：R917[医药卫生—药物分析学]