Study Of The Stability Of Levofloxacin Injection

Ofloxacin(trade name is Tarivid), one of the third group of Quinolones, is made by Daiichi Pharmaceutical Co Ltd.(Japan) in 1982. It is widely used in clinical due to its harmfulless, efficient and broad spectrum especially for Gram-negative Aerobic Bacilli such as most of the Enterobacteriaceaes, Citrobacter, Escherichia coli, Klebsiella, Proteus, Shiga-like toxin, Vibrio, Yersinia enterocolitica etc. Some articles claim many adverse reactions of Levofloxacin Hydrochloride Injection, and some of them are due to the stability. The factors which may have a effect on the stability are the light and temperature, so that crystallization, content decreasing, color change and pH change may happen. These will further effect the safety of Levofloxacin Hydrochloride Injection.The purpose of this thesis is to deal with the problem of stability during the production and storage of Levofloxacin Hydrochloride Injection in order to promote the quality on stability and safety and then have an evaluation for the developed injection.This project improves the prescription and experimental condition to promote the stability with the existing procedure for Levofloxacin Hydrochloride Injection. The evaluation is operated with HPLC under the operation on the 2005 edition of China Pharmacopeia for injection. Tween 80 is used as solubilizing agent, and diluted hydrochloric acid is used to adjust the pH value for the preparation of Levofloxacin Hydrochloride Injection. The final prescription is with 3% Tween 80, good physical stability of Levofloxacin Hydrochloride Injection may have without crystallization during the storage. The relevant substances also comply with the 2005 edition of China Pharmacopeia.This project evaluates the produced Levofloxacin Hydrochloride Injection by the 2005 edition of China Pharmacopeia including properties, pH value, color, relevant substance, heavy metal, insolvable particle, endotoxin, asepsis and content. All these three groups of samples comply with the monograph.This project evaluates the color, pH value, clarity and content of Levofloxacin Hydrochloride Injection for accelerated test and long-term stability test. The result shows the produced Levofloxacin Hydrochloride Injection does not have significance change on color, pH value, color of the solvent, clarity and content. These mean the stability of Levofloxacin Hydrochloride Injection is good.