2012
DOI: 10.1556/achrom.24.2012.1.3
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A validated stability-indicating isocratic LC method for levofloxacin in the presence of degradation products and its process-related impurities

Abstract: The objective of the current study is to develop a validated specific stabilityindicating isocratic reversed-phase liquid chromatographic method for the quantitative determination of levofloxacin and its related substances in pharmaceutical dosage forms in the presence of degradation products and its process-related impurities. Forced degradation studies were performed on levofloxacin as per the International Conference on Harmonisation (ICH)-prescribed stress conditions using acid, base, oxidative, water hydr… Show more

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Cited by 2 publications
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“…[19,20] Because of the various structural features, IMPs and DPs pose risks to patients and compromise the quality of the drug. In the references available to determine and/or identify impurities of levofloxacin, LC methods had been described to control the impurities of levofloxacin by relative retention time, [21][22][23][24][25][26] and LC-MS was used to identify the major DPs. [22,26] Three IMPs and four major DPs of levofloxacin were reported, [21,22,26,27] while the analysis of the trace impurities in levofloxacin is still challenging.…”
mentioning
confidence: 99%
“…[19,20] Because of the various structural features, IMPs and DPs pose risks to patients and compromise the quality of the drug. In the references available to determine and/or identify impurities of levofloxacin, LC methods had been described to control the impurities of levofloxacin by relative retention time, [21][22][23][24][25][26] and LC-MS was used to identify the major DPs. [22,26] Three IMPs and four major DPs of levofloxacin were reported, [21,22,26,27] while the analysis of the trace impurities in levofloxacin is still challenging.…”
mentioning
confidence: 99%