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Method for detecting antioxidant degradation product in sodium chloride injection of levofloxacin lactate

A technology of levofloxacin lactate and sodium chloride injection, which can be applied to measurement devices, instruments, scientific instruments and other directions, and can solve the problems of inability to detect antioxidant degradation products.

Pending Publication Date: 2021-05-11
SHIJIAZHUANG NO 4 PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Aiming at the technical problem that the prior art cannot detect the degradation products of antioxidants that may be contained in levofloxacin lactate injection, the present invention provides a method for detecting the degradation products of antioxidants in levofloxacin lactate sodium chloride injection

Method used

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  • Method for detecting antioxidant degradation product in sodium chloride injection of levofloxacin lactate
  • Method for detecting antioxidant degradation product in sodium chloride injection of levofloxacin lactate
  • Method for detecting antioxidant degradation product in sodium chloride injection of levofloxacin lactate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Preparation of reference substance solution: Mix 2,4-di-tert-butylphenol and 3,5-di-tert-butyl-4-hydroxyphenylpropionic acid reference substance, and prepare with solvent (tetrahydrofuran and methanol at a volume ratio of 1:1) The concentration of 2,4-di-tert-butylphenol was 6.7 μg / mL, and the concentration of 3,5-di-tert-butyl-4-hydroxyphenylpropionic acid was 0.8 μg / mL.

[0043] The HPLC detection conditions of antioxidant degradation products 2,4-di-tert-butylphenol and 3,5-di-tert-butyl-4-hydroxyphenylpropionic acid are:

[0044] Detector: UV detector;

[0045] Detection wavelength: 280nm;

[0046] Chromatographic column: ACQUITY UPLC BEH C18, 2.1*100mm, 1.7μm;

[0047] Mobile phase: acetonitrile-water solution with a volume ratio of 70:30;

[0048] Flow rate: 0.4mL / min;

[0049] Column temperature: 30°C;

[0050] Injection volume: 3μL;

[0051] The elution method is isocratic elution.

[0052] Get the reference substance solution of above-mentioned preparation...

Embodiment 2

[0069] Preparation of reference substance solution: Mix 2,4-di-tert-butylphenol and 3,5-di-tert-butyl-4-hydroxyphenylpropionic acid reference substance, and prepare with solvent (tetrahydrofuran and methanol at a volume ratio of 1:1) The concentration of 2,4-di-tert-butylphenol was 6.7 μg / mL, and the concentration of 3,5-di-tert-butyl-4-hydroxyphenylpropionic acid was 0.8 μg / mL.

[0070] Preparation of the test solution: after taking 50 mL of levofloxacin lactate sodium chloride injection and passing through a solid phase extraction column (Supel-Select HLB SPE, 6 mL), add 5 mL of 0.002 mol / L acetic acid solution, then use 6 mL of methanol and 4 mL of tetrahydrofuran successively For elution, collect the eluent, and use a solvent (tetrahydrofuran and methanol at a volume ratio of 1:1) to set the volume to 10 mL, filter, and use it as the test solution.

[0071] Preparation of the sample addition solution: take 50 mL of levofloxacin lactate sodium chloride injection, accurately...

Embodiment 3

[0111] Cleaning method recovery confirmation:

[0112] Preparation of reference substance solution: Mix 2,4-di-tert-butylphenol and 3,5-di-tert-butyl-4-hydroxyphenylpropionic acid reference substance, and prepare with solvent (tetrahydrofuran and methanol at a volume ratio of 1:1) The concentration of 2,4-di-tert-butylphenol was 6.7 μg / mL, and the concentration of 3,5-di-tert-butyl-4-hydroxyphenylpropionic acid was 0.8 μg / mL.

[0113] The preparation of the test solution: after taking 50 mL of levofloxacin lactate sodium chloride injection through the activated solid phase extraction column (Supel-Select HLB SPE, 6 mL), add 0.002 mol / L acetic acid solution 5 mL, then use 6 mL methanol and 4mL tetrahydrofuran was eluted sequentially, and the eluate was collected, and the volume was adjusted to 10mL with a solvent (tetrahydrofuran and methanol at a volume ratio of 1:1) to obtain a stock solution for future use.

[0114] Precisely measure 1mL of the reference substance solution ...

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Abstract

The invention provides a method for detecting an antioxidant degradation product in a sodium chloride injection of levofloxacin lactate. The sodium chloride injection of levofloxacin lactate is treated by adopting solid-phase extraction, and the step of cleaning the levofloxacin lactate on a solid-phase extraction column by using an acetic acid solution with a specific concentration is added before elution, so that the interference of the levofloxacin lactate on the detection of 2, 4-di-tert-butylphenol and 3, 5-di-tert-butyl-4-hydroxyphenylpropionic acid is avoided; and then ACQUITY UPLC BEHC18 is adopted, an acetonitrile-aqueous solution with the volume ratio of 70: 30 is taken as a mobile phase, and detection is carried out under the detection wavelength of 280 nm. The method has the advantages of high sensitivity, accurate quantification and short detection time, and accurate and quantitative detection of 3, 5-di-tert-butyl-4-hydroxyphenylpropionic acid and 2, 4-di-tert-butylphenol in the sodium chloride injection of levofloxacin lactate can be realized.

Description

technical field [0001] The invention relates to the technical field of drug detection, in particular to a method for detecting degradation products of antioxidants in levofloxacin lactate sodium chloride injection. Background technique [0002] Levofloxacin lactate is a third-generation quinolone broad-spectrum antibacterial drug. Its injection is clinically used to treat infections caused by sensitive bacteria, and its curative effect is definite. At present, levofloxacin lactate injection has been approved for marketing. Infusion products packaged in plastic bottles have the characteristics of light weight, convenient transportation, unbreakable bottle body, easy to guarantee product quality, and convenient opening of bottle caps with the design of easy-pull rings, etc., which are widely used in medical institutions at all levels in my country in recent years. . In addition, since the translucency of the plastic bottle body is weaker than that of the glass bottle, it is ea...

Claims

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Application Information

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IPC IPC(8): G01N33/577
CPCG01N33/577
Inventor 杨俊免马明卓李彪韩倩茹骆会茹宗莹莹崔雪妹郭雅玮
Owner SHIJIAZHUANG NO 4 PHARMA
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