Comparison of the methods for the related substances control of pefloxacin mesylate in Chinese and/or European Pharmacopoeias
Pages: 526-530
Year: 2017 Issue: 6
Journal: Chinese Journal of Antibiotics
Abstract: Objective Different HPLC methods ofrelated substances of pefloxacinmesylate in Chinese Pharmacopoeia (ChP) and European Pharmacopoeia (EP)were compared,and the results of the related substances were compared to evaluate the methods.Methods The analysis methods of pefloxacin mesylate contained in ChP and EP were employed to determine the related substances of pefloxacin mesylate for injection.The methods were comprehensively evaluated regarding the chromatographic features,determination results,the number of impurities,and experimental costs of each method.Results The chromatographic features of two methods were quite different.The maximum impurity and total impurities contents of pefloxacin mesylate injections determined by the two methods were equivalent,but the method in ChP detected more impurities than that in EP,and the HPLC system resolution of ChP was better than EP.Conclusion The method in ChP is superior to that in EP,and can be used to control the related substances ofpefloxacin mesylate injections effectively.
Year: 2017 Issue: 6
Journal: Chinese Journal of Antibiotics
Abstract: Objective Different HPLC methods ofrelated substances of pefloxacinmesylate in Chinese Pharmacopoeia (ChP) and European Pharmacopoeia (EP)were compared,and the results of the related substances were compared to evaluate the methods.Methods The analysis methods of pefloxacin mesylate contained in ChP and EP were employed to determine the related substances of pefloxacin mesylate for injection.The methods were comprehensively evaluated regarding the chromatographic features,determination results,the number of impurities,and experimental costs of each method.Results The chromatographic features of two methods were quite different.The maximum impurity and total impurities contents of pefloxacin mesylate injections determined by the two methods were equivalent,but the method in ChP detected more impurities than that in EP,and the HPLC system resolution of ChP was better than EP.Conclusion The method in ChP is superior to that in EP,and can be used to control the related substances ofpefloxacin mesylate injections effectively.
Related Articles