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

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...

AI Technical Summary

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

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