Method for detecting content of ethylenediamine in medicine by HPLC

A technology of ethylenediamine and content, applied in the field of detection, can solve the problems of mucous membrane and skin irritation, contact dermatitis, corrosion, etc., and achieve the effect of accurate detection results, symmetrical peak shape and good repeatability

Active Publication Date: 2020-09-29
CHENGDU BRILLIANT PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Ethylenediamine is used in medicines as a co-solvent and to adjust the pH value of medicines, but ethylenediamine is corrosive to a certain extent and will irritate the skin and mucous membranes and skin. Contacting the vapor of this product can cause conjunctivitis and bronchitis , pneumonia or pulmonary edema, and contact dermatitis can occur, which can cause liver and kidney damage

Method used

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  • Method for detecting content of ethylenediamine in medicine by HPLC
  • Method for detecting content of ethylenediamine in medicine by HPLC
  • Method for detecting content of ethylenediamine in medicine by HPLC

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Experimental program
Comparison scheme
Effect test

Embodiment Construction

[0038] The experimental process of this application is as follows:

[0039] 1. Analysis method establishment

[0040] Chromatographic conditions to be verified:

[0041] Use octadecylsilane bonded silica gel as filler (Agilent ZORBAX SB C18: 4.6mm×250mm, 5μm or equivalent chromatographic column), and use 5mmol / L ammonium acetate buffer (adjust pH to 6.5 with acetic acid) as the flow In phase A, acetonitrile is used as mobile phase B, and gradient elution is performed; the flow rate is 1.0ml per minute; the detection wavelength is 228nm; the column temperature is 40°C.

[0042] Perform gradient elution as follows:

[0043]

[0044] Preparation assay method:

[0045] Precisely measure 1.0ml of this product, put it in a 100ml measuring bottle, add 9ml of 0.1mol / L hydrochloric acid, 10ml of 0.25mol / L sodium bicarbonate solution (pH=10) and p-toluenesulfonyl chloride solution (take an appropriate amount of p-toluenesulfonyl chloride , add acetone to dissolve and dilute to ma...

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Abstract

The invention particularly relates to a method for detecting a content of ethylenediamine in medicine by HPLC. The method is mainly realized by performing a derivatization reaction on ethylenediaminewithout ultraviolet absorption to obtain a derivative product with ultraviolet absorption. According to the method, the content of ethylenediamine is detected by adopting high performance liquid chromatography, and the method is accurate in detection result, flat in baseline, symmetrical in peak shape, high in stability, good in repeatability, high in separation degree, low in detection limit, high in sensitivity and free of damage to instruments.

Description

technical field [0001] The invention relates to the field of detection methods, in particular to a method for detecting the content of ethylenediamine in medicines. Background technique [0002] Ethylenediamine is a colorless or light yellow oily or watery liquid with an ammonia-like odor and is strongly alkaline. Ethylenediamine is used in medicines as a cosolvent and to adjust the pH value of medicines. However, ethylenediamine is corrosive to a certain extent and will irritate the skin. It is strongly irritating to mucous membranes and skin. Contacting the vapor of this product can cause conjunctivitis and bronchitis. , pneumonia or pulmonary edema, and contact dermatitis can occur, which can cause liver and kidney damage. Therefore, it is very important to accurately detect the content of ethylenediamine in medicines. [0003] For example, Aolibao (common name: lipoic acid injection) of Stadt Pharmaceuticals, Germany, its active ingredient is α-lipoic acid, and the exc...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 唐欢胡崇琳王丽涛肖娟陈礼莉
Owner CHENGDU BRILLIANT PHARMA CO LTD
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