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2015版藥典溶劑殘留測定填充柱
2015版藥典溶劑殘留測定填充柱 詳細信息：

名稱：填充柱
固定相：苯乙烯-二乙烯苯共聚物

規(guī)格：2m*3mm

粒度：60-80目

型號：GDX-101
儀器：島津2014

應(yīng)用：藥典2015溶劑殘留測定：甲磺酸左氧氟沙星中有機溶劑殘留；頭孢菌素類抗生素殘留溶劑的測定

隨著醫(yī)藥工業(yè)技術(shù)的提高以及人民健康水平的提高。各國藥典對藥物質(zhì)量指標提出愈來愈高的要求和標準。

95版中國藥典收入了氣相色譜法測定有機溶劑殘留量。但不同溶劑采用不同柱溫條件測定,甚是麻煩。美國藥典可同時測定多種有機溶劑殘留,但條件苛刻,操作繁復(fù)。

為此,浩瀚色譜（山東）應(yīng)用技術(shù)開發(fā)有限公司并研究提出了同時測定藥物多種有機溶劑殘留量的氣相色譜法。測定條件是:GDX-101填充柱,柱溫150℃,進樣口溫度210℃。氣體流速氮氣50ml/空氣0.5kg/cm~2,氫氣0.5kg/cm~2,檢測器為氫火焰,量程10~3,數(shù)據(jù)處理機衰減值為,進樣濃度按藥典規(guī)定配制,進樣量為3μl。結(jié)果表明:可以同時測定多種溶劑,方法簡便、準確、快速、能滿足藥典要求。


2015版藥典溶劑殘留測定填充柱 測試譜圖：



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:

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