论著

定量检测异丙醇消毒剂含量的气相色谱法的建立与验证

  • 栗妍 李娜 杨冰 李丽 马博 丁玲
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  • 北京生物制品研究所有限责任公司质量检定室 100176

网络出版日期: 2025-08-16

Establishment and verification of a gas chromatography for quantitative determination of isopropanol disinfectant content

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  • Department of Quality Control, Beijing Biological Products Institute Co., Ltd., Beijing 100176,China

Online published: 2025-08-16

摘要

目的  建立一种定量检测异丙醇消毒剂含量的气相色谱法。方法  采用DB-1气相色谱柱,尺寸为30 m(长)×0.53 mm(内径)×3.00 µm(膜厚)。色谱条件如下:程序升温;以氮气为载气,恒定流速5 ml/min;进样口温度为200 ℃,检测器温度为275 ℃;分流进样,进样量1 µl。对该法进行专属性、准确性、重复性、耐用性验证。结果  异丙醇气体和正丁醇气体完全分离,分离度为25.4。该法在考察范围内线性良好,决定系数为0.999 977。正丁醇稀释液色谱图中没有干扰峰出现。3个浓度级异丙醇测试液的回收率为98%~101%。2名分析员分别检测同一样品的6个平行测试液,测定结果的相对标准偏差为0.5%。结论  建
立的方法专属性、准确性、重复性和耐用性良好,可用于异丙醇消毒剂的定量检测。

本文引用格式

栗妍 李娜 杨冰 李丽 马博 丁玲 . 定量检测异丙醇消毒剂含量的气相色谱法的建立与验证[J]. 国际生物制品学杂志, 2019 , 42(3) : 112 -115 . DOI: 10.3760/cma.j.issn.1673-4211.2019.03.003

Abstract

Objective  To establish a gas chromatography for quantitative determination of isopropanol disinfectant. Methods  DB-1 gas chromatographic column was used with a size of 30 m (length) × 0.53 mm (inner diameter) × 3.00 µm (film thickness). The temperature programmed mode was adopted. Nitrogen was used as carrier gas with a constant flow rate of 5 ml/min; the temperatures of inlet and detector were 200 and 275 ℃, respectively. Split sampling with sample size of 1 µl was adopted. The specificity, accuracy, repeatability and durability of the method were verified. Results Isopropanol gas and n-butyl alcohol gas were completely separated with a separation degree of 25.4. The method had good linearity within the scope of investigation and the determination coefficient was 0.999 977. No interference peaks appeared in the diluted n-butyl alcohol chromatogram. The recoveries of isopropanol test solutions at 3 concentrations were between 98% and 101%. When 6 parallel solutions of the same sample were tested separately by 2 analysts, the relative standard deviation of the results was 0.5%. Conclusions  The established method has good specificity, accuracy, repeatability and durability, and can be used for quantitative detection of isopropanol disinfectant.
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