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Method for detecting related substances in levofloxacin hydrochloride tablet

A technology of levofloxacin hydrochloride tablets and a detection method, which is applied in the field of drug detection, can solve the problems of no impurity detection, etc., and achieve the effects of high sensitivity, broad application prospects, and stable analysis methods

Pending Publication Date: 2021-11-12
HAINAN HAISHEN TONGZHOU PHARM CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0004] At present, there are national standards for the determination of related substances in levofloxacin hydrochloride. However, the standards only control individual impurities, other impurities, and the sum of other impurities, but do not detect more specific impurities.

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  • Method for detecting related substances in levofloxacin hydrochloride tablet
  • Method for detecting related substances in levofloxacin hydrochloride tablet
  • Method for detecting related substances in levofloxacin hydrochloride tablet

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Embodiment

[0067] The following examples are used to illustrate the present invention, but are not intended to limit the scope of the present invention.

[0068] A method for detecting related substances in levofloxacin hydrochloride tablets provided by the present invention, the detection method adopts liquid chromatography to detect levofloxacin hydrochloride and related substances in levofloxacin hydrochloride tablets, and the liquid chromatography conditions include: using mobile phase A and The mixture of mobile phase B is eluted, wherein mobile phase A is sodium hexanesulfonate solution, and mobile phase B is methanol; the ratio of mobile phase A to B in the elution process is (1~3):1 , the flow rate is 1.0-2.0ml / min.

[0069] Preferably, the ratio of mobile phase A to B during the elution is 1.8:1, and the flow rate is 1.0ml / min.

[0070] After verification, using the above mobile phase and flow rate, the peak shape of levofloxacin hydrochloride tablets is better, the ratio of mo...

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Abstract

The invention relates to the field of medicine detection, in particular to a method for detecting related substances in levofloxacin hydrochloride tablets. Liquid chromatography is adopted to detect levofloxacin hydrochloride and related substances in the levofloxacin hydrochloride tablets, and liquid chromatography conditions comprise that a mixture of a mobile phase A and a mobile phase B is adopted for elution, the mobile phase A is a sodium hexane sulfonate solution, and the mobile phase B is methanol; in the elution process, the ratio of the mobile phase A to the mobile phase B is (1-3): 1, and the flow velocity is 1.0-2.0 ml / min. According to the detection method, the preparation operation of the mobile phase is simple, the analysis method is stable, the sensitivity is high, the related substances in the levofloxacin tablets can be simply, conveniently, efficiently and comprehensively detected, and process impurities and degraded impurities generated in the preparation, research, detection and storage processes of the levofloxacin hydrochloride tablets are effectively controlled; the method can be used for quality control of the levofloxacin hydrochloride tablets, and has a wide application prospect.

Description

technical field [0001] The invention relates to the field of drug detection, in particular to a method for detecting related substances in levofloxacin hydrochloride tablets. Background technique [0002] Levofloxacin hydrochloride is a third-generation quinolone antibacterial drug. It is the L-body of ofloxacin. Its antibacterial activity is about twice that of ofloxacin. The main mechanism of action is to inhibit the activity of bacterial DNA gyrase, thereby inhibiting the replication of bacterial DNA . Levofloxacin hydrochloride has the characteristics of strong antibacterial efficacy, high safety, and low drug resistance. It has strong antibacterial activity, and also has good antibacterial effect on some Staphylococcus, Streptococcus pneumoniae, Influenza Bacillus, Pseudomonas aeruginosa, Neisseria gonorrhoeae, Chlamydia, etc. [0003] Levofloxacin Hydrochloride Injection is mainly suitable for the treatment or prevention of infections that have been proven or highly ...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/34G01N30/86G01N30/74G01N30/32G01N30/88
CPCG01N30/02G01N30/34G01N30/8634G01N30/74G01N30/32G01N30/88G01N2030/324G01N2030/8872
Inventor 刘玉韦家华王汕桃
Owner HAINAN HAISHEN TONGZHOU PHARM CO LTD
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