Method for detecting N,N-diacetyl lanthionine in acetylcysteine solution

A technology of acetylcysteine ​​and lanthionine, applied in the field of analysis and testing, can solve problems such as unseen and unseen, and achieve the effects of reducing solvent effect, strong method specificity, and good detection accuracy

Inactive Publication Date: 2019-10-15
武汉兴华智慧医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

N, N-diacetyl lanthionine (impurity E) is a specific impurity in acetylcysteine ​​solution for inhalation. So far, there has been no report on the effect of acetylcysteine ​​solution on N, N-diacetylcysteine ​​for inhalation. There is no report on the control of acetyl lanthionine, and there is no report on the control of N,N-diacetyl lanthionine by acetylcysteine-related preparations

Method used

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  • Method for detecting N,N-diacetyl lanthionine in acetylcysteine solution
  • Method for detecting N,N-diacetyl lanthionine in acetylcysteine solution
  • Method for detecting N,N-diacetyl lanthionine in acetylcysteine solution

Examples

Experimental program
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Embodiment 1

[0052] 1. Detection conditions of high performance liquid chromatography:

[0053] Mobile phase: 6.8g / L phosphate buffer-methanol, the volume ratio is 98:2. Among them, the configuration method of 6.8g / L phosphate buffer is as follows: weigh 6.8g of potassium dihydrogen phosphate, add 1000ml of purified water to dissolve , adjust the pH value to 2.0 with phosphoric acid;

[0054] Column: Octadecylsilane bonded silica gel column with an inner diameter of 3.9 mm, a length of 300 mm, and a particle size of 10 μm;

[0055] Detection wavelength: 205nm;

[0056] Column temperature: 25°C;

[0057] Flow rate: 1.5ml / min;

[0058] Injection volume: 20 μl.

[0059] 2. Solution preparation:

[0060] Test solution: Precisely pipette 1ml of acetylcysteine ​​solution (specification: 3ml: 0.3g) for inhalation, dilute with mobile phase so that the content of acetylcysteine ​​per 1ml is 4mg, specific reference, precise pipetting Put 1ml of acetylcysteine ​​solution for inhalation into a...

Embodiment 2

[0122] Only the flow rate in the liquid chromatography detection conditions in Example 1 was adjusted from 1.5ml / min to 1.4ml / min, and the preparation of the solution was the same as in Example 1.

Embodiment 3

[0124] Only the flow rate in the liquid chromatography detection conditions in Example 1 was adjusted from 1.5ml / min to 1.6ml / min, and the preparation of the solution was the same as in Example 1.

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Abstract

The invention discloses a method for detecting N,N-diacetyl lanthionine in an acetylcysteine solution, comprising the steps of: respectively using a mobile phase to dilute the acetylcysteine solutionto be tested and dissolving an N,N-diacetyl lanthionine reference substance to obtain a test solution and a reference substance solution, respectively performing high performance liquid chromatographydetection, and calculating the content of the N,N-diacetyl lanthionine according to the detection result, wherein chromatographic conditions are as follows: chromatographic column: octadecyl silane bonded silica gel column, detection wavelength: 205 + / - 2 nm, and mobile phase: 6.8 g / L of phosphate buffer-methanol solution with a volume ratio of 97.4%: 2.6% to 98.6%: 1.4%. By adopting the method disclosed by the invention, the N,N-diacetyl lanthionine in the acetylcysteine solution can be effectively detected, furthermore, there is no interference, and the specificity is high; the detection limit and the quantification limit are respectively 8 ng and 32 ng, and quantitative detection can be realized; detection accuracy is relatively good; and the application prospect is broad.

Description

technical field [0001] The invention belongs to the technical field of analysis and testing, and relates to a detection method for impurities in acetylcysteine, in particular to a detection method for N,N-diacetyllanthionine in an acetylcysteine ​​solution. Background technique [0002] Acetylcysteine ​​(Acetylcysteine) has been widely used clinically as an expectorant since the 1960s, and it is an expectorant with the most comprehensive mechanism of action in clinical practice. Since acetylcysteine ​​contains a sulfhydryl group (-SH), it can break the disulfide bond (-S-S-) in the polypeptide chain, reduce the viscosity of sputum, make the sputum easy to discharge, and stimulate the movement of airway epithelial cilia. Enhances sputum clearance. [0003] At present, acetylcysteine ​​has dosage forms such as granules, tablets, injections, eye drops and inhalation solutions in China. Compared with oral preparations and injections, acetylcysteine ​​solution for inhalation ca...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/36G01N30/74
CPCG01N30/02G01N30/06G01N30/36G01N30/74G01N2030/027
Inventor 卢山余熙文
Owner 武汉兴华智慧医药科技有限公司
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