New and simple HPLC method for the determination of lactic acid content in ciprofloxacin injection

摘要

A simple reversed-phase HPLC method was developed for routine analysis of lactic acid in Ciprofloxacin Injection. The analysis involves simple sample preparation to ensure complete hydrolysis of the oligomers of lactic acid. Using these conditions, recoveries ranging from 97.5 to 99.9% at three levels of the label claim were obtained. The standard solution and the sample solution were shown to be stable for at least 41 hours when stored at room temperature. Tests done have also demonstrated that the method is stable despite small changes in experimental conditions. Data supporting the development and validation of this method are presented.