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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

李苏芹 张宏文 吴金凤 肖旭东 孙鲁宁

中国医学装备Issue(10):23-26,4.
中国医学装备Issue(10):23-26,4.DOI:10.3969/J.ISSN.1672-8270.2015.10.007

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

李苏芹 1张宏文 1吴金凤 1肖旭东 2孙鲁宁2

作者信息

  • 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
  • 折叠

摘要

Abstract

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

Key words

Micro infusion pump connecting pipe/Reversed phase-high performance liquid chromatography/Octreotide acetate/Determination of residual liquor

分类

医药卫生

引用本文复制引用

李苏芹,张宏文,吴金凤,肖旭东,孙鲁宁..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[J].中国医学装备,2015,(10):23-26,4.

基金项目

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” (11210003)

中国医学装备

OACSTPCD

1672-8270

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