Improvement of Tests for the Control of Impurities in Antimicrobial Medicinal Products by Chromatographic Methods: Ciprofloxacin Case Study

Abstract

The need to reduce analysis time when controlling impurities in medicinal products remains an urgent challenge. The aim of the study was to use the example of ciprofloxacin in order to select chromatographic conditions that will significantly accelerate and simplify determination of impurities in medicinal products. Methods: the study was performed using the Chromolith ® Performance RP-18e 100×4.6 mm and Acquity UPLC BEH C18 1.7 μ m, 100×2.1 mm columns and the Agilent 1290 Infinity chromatography system with a diode array detector. Results: the authors of the study worked out gradient elution modes for determination of ciprofloxacin impurities that involved 15 min run time for fast high-performance liquid chromatography and 12 min run time for ultra-performance liquid chromatography. The identification of impurities was performed based on relative retention times of impurity peaks and their comparison with the reference standard chromatogram. Conclusions: the study demonstrated the possibility of replacing the thin-layer chromatography method used for determination of fluoroquinolonic acid (ciprofloxacin impurity A) with high-performance liquid chromatography. The proposed test conditions allow for identification of ciprofloxacin impurities specified in well-established pharmacopoeias and manufacturers’ product specification files. The obtained data may be used for further development of rapid methods of ciprofloxacin impurities determination in medicinal products.