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Method for determining photodegradation impurities in levofloxacin raw material and levofloxacin preparation

A levofloxacin and photodegradation technology, which is applied in the direction of measuring devices, material separation, and analysis of materials, can solve the problems that cannot meet the limit detection sensitivity requirements and the low response value of diformyl impurities, and is conducive to safe promotion and application. The effect of good accuracy and high precision

Inactive Publication Date: 2020-07-28
SHANDONG QIDU PHARMA
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Problems solved by technology

[0007] In the existing quality standards of levofloxacin raw materials and preparations, including "Chinese Pharmacopoeia", "US Pharmacopoeia", "Japanese Pharmacopoeia", "European Pharmacopoeia" and other standards, the inspection methods for related substances listed, the response of diformyl impurities Values ​​are all low, can't meet limit detection sensitivity requirement, therefore, need to provide a kind of detection method of levofloxacin diformyl body impurity

Method used

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  • Method for determining photodegradation impurities in levofloxacin raw material and levofloxacin preparation
  • Method for determining photodegradation impurities in levofloxacin raw material and levofloxacin preparation
  • Method for determining photodegradation impurities in levofloxacin raw material and levofloxacin preparation

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Embodiment 1

[0041] The method for measuring photodegradation impurities in levofloxacin raw materials and preparations is measured by high performance liquid chromatography, and the chromatographic conditions are as follows:

[0042] Chromatographic column: use aminosilane-bonded silica gel as filler, 4.6×250mm, 5μm;

[0043] Mobile phase: acetonitrile-0.05mol / L potassium dihydrogen phosphate solution (adjust pH to 5.3 with sodium hydroxide test solution) (70:30);

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Abstract

The invention belongs to the field of drug detection, and particularly relates to a method for determining photodegradation impurities in a levofloxacin raw material and a levofloxacin preparation. The method comprises the following steps: (1) preparing a levofloxacin photodegradation impurity standard solution; (2) injecting the standard solution into a high performance liquid chromatograph for determination, and constructing a standard curve by taking the concentration of the standard solution as an abscissa and the peak area as an ordinate; (3) preparing a to-be-detected sample solution; and (4) injecting the to-be-detected sample solution into a high performance liquid chromatograph for determination, recording the peak area of the to-be-detected sample solution, and calculating the content of the photodegradable impurities by using the standard curve. According to the method, high performance liquid chromatography is adopted, amino silane bonded silica gel is used as a stationaryphase, a mixed solution of acetonitrile and 0.05mol / L monopotassium phosphate solution is used as a mobile phase, and an isocratic elution mode is adopted. The method is high in specificity, high in precision, good in accuracy and capable of effectively detecting the content of photodegradation impurities in levofloxacin raw materials and preparations.

Description

technical field [0001] The invention belongs to the field of drug detection, in particular to a method for determining photodegradation impurities in levofloxacin raw materials and preparations. Background technique [0002] Levofloxacin, chemical name is (-)-(S)-3-methyl-9-fluoro-2,3-dihydro-10-(4-methyl-1-piperazinyl)-7oxo-7H- Pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate with the formula The molecular weight is 370.38, and the chemical structural formula is: [0003] [0004] Levofloxacin was launched in Japan in 1993. The drug has achieved good efficacy in the treatment of respiratory tract infections, urogenital infections and skin and soft tissue infections. Among them, the effective rate and bacterial clearance rate of acute and chronic lower respiratory tract infections are 80-100%, and the clearance rate for Haemophilus influenzae, Moraxella catarrhalis, Staphylococcus aureus and pneumococcus is high, while for Pseudomonas aeruginosa Bacillu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/86
CPCG01N30/02G01N30/06G01N30/8675G01N2030/045
Inventor 周玲玲张楠楠宋连杰王娜廖信信扈长青陈延华马莹莹白臣生杨云娟
Owner SHANDONG QIDU PHARMA
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