岛津GDX-101 2015版药典溶剂残留测定填充柱

名称：填充柱
固定相：苯乙烯-二乙烯苯共聚物

规格：2m*3mm

粒度：60-80目

型号：GDX-101
仪器：岛津2014

应用：药典2015溶剂残留测定：甲磺酸左氧氟沙星中有机溶剂残留；头孢菌素类抗生素残留溶剂的测定

随着医药工业技术的提高以及人民健康水平的提高。各国药典对药物质量指标提出愈来愈高的要求和标准。

95版中国药典收入了气相色谱法测定有机溶剂残留量。但不同溶剂采用不同柱温条件测定,甚是麻烦。美国药典可同时测定多种有机溶剂残留,但条件苛刻,操作繁复。

为此,浩瀚色谱（山东）应用技术开发有限公司并研究提出了同时测定药物多种有机溶剂残留量的气相色谱法。测定条件是:GDX-101填充柱,柱温150℃,进样口温度210℃。气体流速氮气50ml/空气0.5kg/cm~2,氢气0.5kg/cm~2,检测器为氢火焰,量程10~3,数据处理机衰减值为,进样浓度按药典规定配制,进样量为3μl。结果表明:可以同时测定多种溶剂,方法简便、准确、快速、能满足药典要求。


2015版药典溶剂残留测定填充柱 测试谱图：



Packed column for determination of solvent residue in Pharmacopoeia of 2015 edition
Packed column for determination of solvent residue in the 2015 Pharmacopoeia Details:

Name: Packed column
Stationary phase: styrene-divinylbenzene copolymer

Specification: 2m*3mm

Granularity: 60-80 mesh

Model: GDX-101

Application: Pharmacopoeia 2015 solvent residue determination: organic solvent residue in levofloxacin mesylate; determination of cephalosporin antibiotic residue solvent

With the improvement of pharmaceutical industry technology and the improvement of people's health. Pharmacopoeias of various countries have put forward higher and higher requirements and standards for drug quality indicators.

The 95th edition of the Chinese Pharmacopoeia includes gas chromatography for the determination of residual organic solvents. However, it is very troublesome to use different column temperature conditions for the determination of different solvents. The United States Pharmacopoeia can simultaneously determine the residues of a variety of organic solvents, but the conditions are harsh and the operation is complicated.

To this end, Haohan Chromatography (Shandong) Applied Technology Development Co., Ltd. has also researched and proposed a gas chromatography method for simultaneous determination of multiple organic solvent residues of drugs. The measurement conditions are: GDX-101 packed column, column temperature 150℃, and inlet temperature 210℃. The gas flow rate is nitrogen 50ml/air 0.5kg/cm~2, hydrogen gas 0.5kg/cm~2, the detector is a hydrogen flame, the range is 10~3, the attenuation value of the data processor, the injection concentration is prepared according to the pharmacopoeia, the injection volume It is 3μl. The results show that: multiple solvents can be determined simultaneously, the method is simple, accurate, fast, and can meet the requirements of the pharmacopoeia.


Test spectrum of packed column for determination of solvent residue in Pharmacopoeia of 2015 edition: