Preparation, characterization and stability of three forms of prulifloxacin

doi:10.19803/j.1672-8629.20230093

Abstract

Abstract: Objective To study the polymorphism of prulifloxacin and provide a scientific basis for the quality control of the polymorphic impurities in the drug. Methods Three forms of prulifloxacin (formⅠ, formⅡ and form Ⅲ) were prepared. The forms were characterized by using powder X-ray diffraction, infrared spectroscopy, differential scanning calorimetry and Raman spectroscopy, and the stability relationship and crystal transformation rules of the three forms were explored by suspension experiments. Results Powder X-ray diffraction, infrared spectroscopy, thermal analysis and Raman spectroscopy were used to identify the three polymorphs of prulifloxacin effectively. The stability relationship of forms is: formⅠ> formⅡ > form Ⅲ. Conclusion This study provides references for the formulation of the standard of prulifloxacin.

Key words: prulifloxacin, polymorphism, characterization, stability, powder X-ray diffraction, infrared spectroscopy, differential scanning calorimetry, Raman spectroscopy

CLC Number:

R917

HUANG Yinyin, ZHANG Liwen, LIU Jing, CHEN Jing, ZHOU Yuanhua, XU Mingzhe, YAO Shangchen, WANG Chen, ZHANG Xianhua. Preparation, characterization and stability of three forms of prulifloxacin[J]. Chinese Journal of Pharmacovigilance, 2023, 20(4): 374-378.

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